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*T-Shirt Catcher Job Description* *Job Overview* We are seeking a dedicated and detail-oriented T-Shirt Folder to join our production team. In this role, you will be responsible for catching and handling freshly printed t-shirts as they come off the production line. Your attention to detail and ability to work efficiently in a fast-paced environment will contribute to the overall success of our manufacturing process. *Responsibilities* * Catch and properly handle t-shirts from the printing press, ensuring they are free from defects. * Organize, count, and stack finished products for quality control checks. * Assist with materials handling throughout the production area. * Collaborate with team members to maintain a smooth workflow on the assembly line. * Follow safety protocols and maintain a clean work environment. * Ability to stand for extended periods and perform repetitive tasks with precision * Strong organizational skills and a proactive attitude towards maintaining high standards of cleanliness *Skills*: * Basic math skills, able to count and memorize numbers. * Strong attention to detail and a good eye for colors. * Works well in a team setting. * Spanish speaking Join our team and play a vital role in delivering high-quality t-shirts while developing your skills in a dynamic manufacturing environment! Pay: $17.50 - $19.00 per hour Benefits: * 401(k) * 401(k) matching Work Location: In person
*About Us:* LIGHT Helmets is a leader in football safety equipment, dedicated to providing top-quality helmets for all levels of play. We are currently seeking a detail-oriented and skilled individual to join our team as a Helmet Assembly Technician & Reconditioning Specialist. *Key Responsibilities:* * Assemble helmets according to company specifications and safety standards * Inspect, repair, clean, and recondition used helmets to ensure they meet safety and quality guidelines * Perform quality control checks throughout the assembly and reconditioning process * Maintain and organize tools, equipment, and workstations * Follow safety protocols and company procedures to ensure a secure working environment * Assist in inventory management of helmet components and supplies * Work collaboratively with the production team to meet deadlines and efficiency goals *Qualifications & Skills:* * Previous experience in assembly, manufacturing, or a similar technical role is preferred * Strong attention to detail and ability to work with small components * Basic mechanical skills and familiarity with hand tools * Ability to stand for extended periods and perform repetitive tasks * Understanding of safety standards and quality control procedures * Good communication skills and the ability to work in a team environment * Football experience is a plus *Benefits:* * Opportunities for training and career growth * Exciting culture with the fastest growing sports equipment company Please apply directly through Indeed. Pay: $19.50 per hour Benefits: * Employee discount * On-the-job training Work Location: In person
*Sol-ti Production Lead* _*Sol-ti is the Highest Velocity Refrigerated Beverage Company in the United States*_ *Sol-ti’s success resides in consistently developing the highest quality Living Beverages backed by our Employee-Owned team that brings energy and excitement into their daily work with a passion for healthy living and sustainability. * *Sol-ti means ‘of the sun’ or ‘you are the sun’. We are committed to helping individuals shine while also preserving the planet with the use of sustainable glass packaging.* _*Career Basics*_ Location: San Diego, CA Industry Type: Manufacturer Category: Operations Beverages: SuperFood Beverages, Wellness Shots, Functional Beverages Employment Type: * Full Time Position * 12 Hour Shifts * Weekends Reports to: Assistant Manager, Juice Production # of Direct Reports: 8-10 _*Position Summary*_ The Production Lead is responsible for overseeing daily production operations for their shift, ensuring efficiency, quality, and safety standards are consistently met. This role acts as a bridge between management and production staffteam, coordinating workflows, resolving issues on the floor, and driving continuous improvement initiatives. _*Career Responsibilities*_ * Following all good manufacturing policies within the facility. * Lead and supervise production team members during assigned shifts * Plan, organize, and monitor daily production schedules to meet targets * Ensure product quality standards and specifications are consistently achieved * Identify and resolve production issues in real time to minimize downtime * Wear and enforce the proper personal protective equipment usage. * Follow proper FiFo protocols. * Help Maintain Accurate Inventory of all production items. * Order all items needed from Arjons DC. * Ability to properly utilize ATP swabs and record results accurately * Properly set up and breakdown Production Run Line. Which includes the following: · Produce Wash accurately Titrated · Produce Elevator · Grinder · Auger · SX-280 Press · Zumex Citrus Extractor · Pulp filtration system · All supporting equipment * Work with maintenance to timely and accurately report equipment issues. Ability to troubleshoot basic issues and provide information to maintenance team. * Ability to follow recipe accurately and complete simple volume calculations Ability to mix base recipes and process according to SOP * Understand and demonstrate proper use of UV system. * Proper CIP/SIP procedures. · UVs · Tanks · Totes · Process Lines · Additional * Train, coach, and mentor team members to improve performance and skills * Enforce safety protocols and maintain a clean, organized work environment * Collaborate with cross-functional teams (quality, maintenance, inventory, packaging, lwarehousing) * Track production metrics and report on performance, output, and efficiency * Maintain proper documentation and ensure compliance with company policies and food safety standards * Complete any additional task Requested by Plant Manager _*Career Requirements/What we ask of you*_ * Ability to stand on your feet for duration of 12 hour shift * Calculate personnel required to meet daily plan and able to adjust accordingly * Evaluations of temporary employees. * Required to manage team breaks and lunches. * Consistent and reliable attendance * Clear communication * Able to lift 50 lbs. _*What we offer you*_ · Employee Equity Incentive Plan · Performance-based bonuses · Health Insurance programs with industry leading contributions towards your premium · Referral Programs and free access to our functional beverages and supplements to enjoy while at work or home · 80 hours of paid time off, two floating holidays and eight paid company holidays. _*Sol-ti Values*_ We each have an inner light. At Sol-ti, we encourage you to Let Yourself Shine while also encouraging others to shine their brightest. We are committed to helping individuals shine through Liquids of Vitality while also preserving the planet with the use of sustainable glass packaging. _*Create the Best Product: Best in Glass*_ Did you know that most of the other beverages on the market use petroleum based single-use plastic packaging? Not only is this harmful to our oceans and landfills, it is also not sustainable. From the start, we have been committed to bottling in glass for purity, people, and the planet. Our unique UV Light Filtration process uses light rays to preserve our liquid without pasteurizing it – eliminating spoilers without pasteurizing it – so you can enjoy organic, Glass Bottled, Living Beverages. _*How to Apply or Inquire for More Information:*_ Email your resume to Veronica Mathiasen, HR Manager, veronica@solti.com Pay: $24.00 - $26.00 per hour Benefits: * Dental insurance * Health insurance * Paid time off * Referral program * Vision insurance Work Location: In person
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. About this role: Perform quality activities to support manufacturing and sustaining of existing products. Provide quality support to appropriate groups: engineering, manufacturing, quality and design assurance, system/services, incoming/line/final inspection and post market, etc. Develop, apply, monitor, measure, document, improve, and communicate quality methodologies from prodcut development through end of life of a product. Work Mode At Boston Scientific, we value collaboration and synergy. This role follows a onsite work model, requiring employees to be in our local office five days per week. Relocation Relocation assistance is not available for this position at this time. VISA Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time Your responsibilities will include: Perform process monitoring using sampling plans to ensure established controls are being followed. Perform sampling inspection on product using visual and mechanical inspection techniques. Inspect labels, including final packaging labels, for legibility and accuracy. Perform shop-floor paperwork review. Enforce good documentation practices in all documents used during product assembly (DHR, forms, test data sheets, records, etc.). Approve and release finished goods once the inspection is complete (Active Release). Perform process assessments to ensure compliance to appropriate Boston Scientific procedures. Oversee Product Builder/Inspectors Visual Assessment Certifications. Initiate, investigate, and assist in generation and completion of NCEPs. Peform analysis for product returns to determine failure root cause Document failure analysis results in appropriate system Perform product return sample preparation including decontamination, product disposition as needed Perform routine lab work i.e. ensuring lab equipment is properly calibrated Comply with assigned responsibilities as per applicable non-conforming material and rework procedures, which may include: a) Segregate and identify non-conforming material, both physically and electronically (non-conforming material control). b) Execute re-evaluation activities on reworked product. Verify returned material to BSN. Review Return Goods per company procedures. Identify, prioritize and resolve quality issues identified by metrics. Identify and lead departmental initiatives related to best quality practices and continuous improvement. Assist the quality supervisor or other departments in specific tasks (e.g. investigations). Perform “special” quality initiatives using written guidance. Required qualifications: 2-4 Years with High School Diploma and/or Equivalent experience, training , or apprenticeships Requisition ID: 627132 Minimum Salary: $ 56576 Maximum Salary: $ 96200 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Process Engineer I – Engineered Technical Ceramics Full Time + Benefits (Medical, Dental, Vision, 401k with Company Match, PTO) Job Type: Onsite Salary Range: $78,600 - $90,300 DOE Location: Poway, CA Fralock is an engineered solutions provider of specialty components and subassemblies using advanced materials for high reliability, severe environment, and technically challenging applications. We develop and manufacture custom integrated solutions. Established in 1967, we are a critical solutions provider to Fortune 500 corporations, government, and targeted OEMs in a variety of industries including Semiconductor Equipment Manufacturing, Medical and Life Science, Aerospace and Defense , Industrial, Electronics, and Energy. Fralock is headquartered in Valencia, CA with manufacturing locations located throughout Northern and Southern California. VISION To be recognized by our customers as a leading solutions provider of proprietary engineered advanced materials for high reliability, severe environment, and technically challenging applications. MISSION To create value, profitably grow, and share our success with all stakeholders. CULTURE Respect – We treat others the way they want to be treated. Integrity – We practice a high standard of ethics in our business dealings with customers, suppliers and employees. Responsiveness – We have a sense of urgency in responding to internal and external requests and work proactively to solve problems. Excellence/Competence – We empower our people to continuously improve and execute high quality work. Teamwork – We work together to achieve Fralock business objectives by communicating at a high level, by listening and having clarity in our expectations of one another. Individual Accountability and Personal Responsibility – We do what we have committed to do when we committed to doing it. Continuous Improvement across all segments of the company This position requires access to information controlled under the International Traffic in Arms Regulations (ITAR) or the Export Administration Regulations (EAR), the successful candidate must be a "U.S. person" as defined in the ITAR and EAR (which generally means (i) be a citizen or national of the United States; or (ii) be a lawful permanent resident of the United States; or (iii) have been admitted to the United States as a refugee, or have been granted asylum, as specified under applicable law. Job Summary Fralock is seeking a materials engineer or process engineer with 0-2 years of experience in product development and process/manufacturing engineering to join our team in Poway, CA. The process engineer I role is responsible for technical/operational ownership of complex development programs within guidance from senior engineering and product/program management. The Process Engineer I will collaborate and support key projects focused on evaluating process capability and stability for slip casting, paste formulation, sintering, detailed assembly and inspection equipment. This key hire will report to the Poway site engineering leadership while working and collaborating closely with Engineering, Quality, and Operations Managers to ensure the overall success of this growing segment of business at Fralock. Key Responsibilities Supports new product introduction (NPI) programs on behalf of product management, production and engineering. Participates in design reviews and contributes technical expertise for product feasibility and ideal manufacturing methods and implementation to design engineering. Owns development of project planning documents, including project/program scheduling, test plans and resource planning. Assist with formulating and improving travelers using operator provided data, making changes in ERP software. In timely manner, collaborate with quality and manufacturing resources to determine defect root causes, propose and implement corrective actions (immediate, and longer term) and document any manufacturing changes via travelers (operator, supervisors, managers). Evaluate manufacturing process capability (SPC), methods and tooling, applying Lean and Six Sigma principles. Responsible for monitoring furnace process performance, thermal consistency, shrink variability, and dye check yields. Editing and adjusting work instructions and/or process parameters as needed. Responsible for material lot release process testing, evaluating, and tracking material key properties for ceramic products. Work with engineering, operations and vendors to develop cost estimates and proposals Responsible for assisting and troubleshooting existing manufacturing processes Lead realization of work instructions and training for key selected processes Support tactical projects resulting from customer RMAs or audit findings, working to understand their root cause, to improve/amend documentation and procedures Required Skills Strong computer skills Excellent verbal and written communication skills Ability to analyze data and problem solve Ability to read and interpret engineering drawings Knowledge and application of failure mode analysis techniques as applied to both process development and process improvement Ability to realize and implement Design of Experiments to improve process capabilities Ability to use hand tools such as micrometer, calipers, and Archimedes scales. Pa Preferred Skills Self motivated, results and action oriented, and a strong team player A hands on aptitude Process Engineering knowledge Experience in ceramic and/or glass component manufacturing Ceramic powder handling and process in knowledge Experience with multilayer ceramic manufacturing Experience with high temperature material interactions and sintering Demonstrated history of running self-directed projects, managing timelines and executing projects in an R&D environment. CAD/CAM software experience and proficiency Experience interpreting FEA/CFD results Hands-on mechanical and/or thermophysical measurement testing experience Familiarity with navigating ERP and QMS systems to locate data Knowledge of Lean Manufacturing, Just In-Time, Kanban principles Knowledge of ISO 9001, AS9100 or ISO 13485 Experience Requirements 0-2 years in a technical engineering role Experience in one or more related engineering areas: ceramics manufacturing, sintering, industrial, production, or quality Education Requirements Bachelor’s degree in Materials Science and Engineering preferred or an Engineering related discipline. All offers of employment at Fralock are contingent upon clear results of a background check. Background checks may include some or all the following depending on job title and responsibilities: Social Security Verification Prior Employment Verification Criminal History Personal and Professional References Motor Vehicle Records Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of a position. Fralock provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. As a member of the manufacturing team at Abzena, you will be responsible for executing daily task in strict compliance with manufacturing batch records, SOP’s, and Good Manufacturing Practices (GMP). You will take ownership of the production process, facility, and environment to ensure smooth operations. Additionally, you will collaborate cross-functionally with key departments, including QA, MS&T, Facilities, and others to support successful and compliant manufacturing activities and responsibilities. Responsibilities Operate under cGMP manufacturing conditions. Ensure compliance to training on all activities prior to GMP execution. Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes. Ensures right-the-first-time performance of all process steps. Perform production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills. Escalate process related issues as they arise Inventory manufacturing lab supplies and ensure items are properly stocked. Participate in batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Maintain cleanroom standards for cleanliness and order Conduct activities in support of production schedules as directed by senior staff. Work effectively and efficiently in a team environment. Communicate effectively with clients, supervisors, colleagues, and staff. and provide status of floor operation to leads on a regular basis. Support multiple projects simultaneously. Crosstrain on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group. Perform manufacturing and process development activities for projects and products in collaboration with others. Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements. Review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including weekend work, as needed. Perform additional duties as assigned. Qualifications A minimum of 2 years of experience in a GMP pharmaceutical/biotech environment role with a technical degree or equivalent combined years of both. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Experience with aseptic handling, including BSC operations to maintain the integrity of sterile systems. Knowledge of purification using column chromatography Experience using single-use technologies, such as tube welding, tube sealing, and disposable systems A proven ability to confidently compute basic arithmetic operations. FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Manufacturing Associate I will primarily be responsible for performing all aspects of biologics production in a single use facility, including cell vial thaw and inoculum train expansion inside a Bio-Safety Cabinet, operation of wave and stirred-tank bioreactors up to 2000 L, clarification and sterile filtration, and master cell bank fills. In addition, this role will include operation of chromatography skids in conjunction with multi-use and single-use columns, processing intermediates by depth filtration, ultrafiltration and diafiltration, and performing bulk drug substance fills. Responsibilities Operate under cGMP manufacturing conditions Ensure compliance to training on all activities prior to GMP execution. Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes Setup, operate and maintain bioprocessing equipment including single-use bioreactors up to 2000 L, large scale filtration skids, and automated filling machines and analytical instruments for cell culture such as Nova Bioprofile and Vi-Cell systems Perform production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills Setup, operate and maintain bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE Perform production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills Troubleshoot process related issues as they arise Inventory manufacturing lab supplies and ensure items are properly stocked. Participate in batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging Maintain cleanroom standards for cleanliness and order Conduct activities in support of production schedules as directed by senior staff Work effectively and efficiently in a team environment Communicate effectively with clients, supervisors, colleagues, and staff, and provide status of floor operation to leads on a regular basis Support multiple projects simultaneously Cross-train on various tasks including formulation of media and buffers, and operations to support overall success of the Biologics group. Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements Review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation Adhere to quality standards set by regulations and Abzena policies, procedures, and mission Operate to the highest ethical and moral standards Perform additional duties as assigned Qualifications 1 – 2 years cell culture experience in a GMP pharmaceutical/biotech environment role with a technical degree or equivalent combined years of both Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. A proven ability to confidently compute basic arithmetic operations. FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
ABOUT THE BRAND: Callaway Golf Company is a premium golf equipment, gear and apparel company with a portfolio of global brands, including Callaway Golf, Odyssey, TravisMathew, and OGIO. Through an unwavering commitment to innovation and premium craftsmanship, Callaway designs, manufactures, and sells high-performance golf clubs, golf balls, apparel, bags, and other accessories—setting the standard for performance in the game of golf. Our Mission: To create demonstrably superior and pleasingly different products powered by innovative technology and premium craftsmanship enabling golfers of all abilities to play their best and find more joy in the game. Our company is a blend of experience and diverse backgrounds, and together we look to leave the past behind while moving the game forward. For more information, please visit https://www.callawaygolf.com JOB OVERVIEW Under direct supervision, the Source Inspector is responsible for assisting daily product and process audits (using approved procedures, standards, and specifications), product disposition and/or measuring supplier compliance. ROLES AND RESPONSIBILITIES Assists in conducting, reviewing and reporting on audits. Assist in identifying, organizing, and summarizing evidence to support conclusions about compliance to standards (such as PCPs) to SI Lead and Supervisor. Assist in identifying, documenting, recommending, disposition of non-conforming products. Assist with the maintenance of product quality standards documentation and physical samples. Assist with the data collection, reporting and analysis of defects. Assist to maintain the equipment, tools and facilities, keeping sufficient material and supplies. Support SI Leads, Supervisor, and engineering on data collecting, data entry, and data analysis. Process SI daily inspection data into SAP system. TECHNICAL COMPETENCIES (Knowledge, Skills & Abilities) Understanding of production processes (assembly, inspection, packaging, material handling). Knowledge of quality standards and requirements contained in them. Knowledge of general audit terminology. Understanding of variation and common and special causes. Able to understand new product specifications and shop floor work instructions. Basic level skill in any e-mail application, MS Word and Excel, and basic level skill in power point. Basic level skill in raw data collecting and various quality tools (histograms, cause-and-effect diagrams, pareto charts, and run charts) Understand and apply basic conflict management techniques, effective listening skills, and assertive communication methods. Strong initiative to complete assignments. EDUCATION AND EXPERIENCE At least 3 years of High School / Technical School Diploma required Minimum 1 year experience as a process and product auditor/inspector in a manufacturing setting, preferably golf club assembly. DE&I and EEOC: Inclusion & Diversity: As a purpose-led, performance driven company, we strive to foster a culture of belonging based on respect, connection, openness and authenticity. We are committed to building and maintaining a workplace that celebrates the diversity of our associates, supporting them to bring their authentic selves to work every day. If your experience is close to what we’re looking for, please consider applying. Experience comes in many forms, skills are transferable, and passion goes a long way. We know that diverse backgrounds and experiences make for the best problem-solving and creative thinking, which is why we’re dedicated to adding new perspectives to the team and encourage everyone to apply. We look forward to learning more about you. ARE YOU READY TO MAKE THE TURN? APPLY TODAY! 0.00 - 0.00 - 0.00 USD Hourly
Position Summary: The Project Engineer coordinates and ensures the completion of projects and ensures work is in line with customer and regulatory requirements. This is a 100% onsite position at our Vista, CA facility. Relocation assistance and visa sponsorship is not offered. Essential Duties and Responsibilities: Review and monitor program progress and expedite critical path and processes to maintain schedule Assure product and process quality by designing inspection methods, establishing standards and confirming manufacturing processes. Provide support for QA, Supply Chain and suppliers about drawing interpretation, manufacturing methods, inspection methods, etc. Evaluate non-conforming materials, including analyzing the non-conformance for fit, function, safety, and reliability, and communicating with QA, Supply Chain and suppliers, as required. Completing Engineering Changes with supporting substantiation and drawing changes as required for product improvement. Provide support for customers and operators regarding our products. Participate in design reviews for supplier changes, product changes and/or improvements for production parts. Perform reviews of first article inspections and documentation for dormancy and supplier changes of production parts. Review and provide feedback to suppliers on the manufacturing process plans for production parts. Develop test plans for production parts. Design tooling and/or fixtures to aide in the inspection of production parts. Required participation in internal training as needed to perform the duties assigned to this role. Other related duties may be assigned. Estimated Salary Range: $90-135k Requirements: Minimum Qualifications (Knowledge, Skills and Abilities) Required composite fabrication experience. (Layup, Curing, Assembly) U.S. Person status required do to export control Bachelor's Degree in engineering or related field, or combination of education and work experience 10 years aerospace, mechanical design, and or manufacturing experience is required. Strong attention to detail Capable of standing and or sitting for extended periods of time Ability to communicate effectively with coworkers and the management team. Must be well organized, flexible, and able to work in a fast-paced manufacturing environment Must thrive in a team-oriented and deadline-driven environment Ability to verbally communicate, read and comprehend written and verbal instructions in English Familiarity and skill with interpreting technical drawings and blueprints Experience using 3D CAD software (Pro-Engineer, SolidWorks, etc.). Knowledge of Geometric Dimensioning & Tolerance and Standard Measurement & Test Equipment for Aerospace products is preferred. Knowledge of conventional aerospace manufacturing methods is preferred. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Strong organizational skills, ability to multitask and prioritize as necessary, with minimal supervisory direction. Must possess a high level of commitment to quality and customer satisfaction. Highly skilled in MS Office programs- Excel, Word, Outlook, Power Point and Adobe Acrobat Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made. While performing the duties of this job, the employee is regularly required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. Constant specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. The employee may occasionally lift and /or move up to 25 pounds. The employee sits for extended periods of time at a computer station or work desk and is exposed to typical office environment conditions and noise levels. Required to wear Personal Protective Equipment (PPE) when working on the manufacturing floor where the employee may be exposed to moving mechanical parts and is occasionally exposed to high, precarious places; fumes or airborne particles; outside weather conditions; extreme heat and risk of electrical shock. The noise level in the manufacturing floor is usually loud. Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.
San Diego, CAManufacturing – Manufacturing /Full Time /On-Site With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Manufacturing Associate I will primarily be responsible for performing all aspects of biologics production in a single use facility, including cell vial thaw and inoculum train expansion inside a Bio-Safety Cabinet, operation of wave and stirred-tank bioreactors up to 2000 L, clarification and sterile filtration, and master cell bank fills. In addition, this role will include operation of chromatography skids in conjunction with multi-use and single-use columns, processing intermediates by depth filtration, ultrafiltration and diafiltration, and performing bulk drug substance fills. Responsibilities Operate under cGMP manufacturing conditions Ensure compliance to training on all activities prior to GMP execution. Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes Setup, operate and maintain bioprocessing equipment including single-use bioreactors up to 2000 L, large scale filtration skids, and automated filling machines and analytical instruments for cell culture such as Nova Bioprofile and Vi-Cell systems Perform production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills Setup, operate and maintain bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE Perform production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills Troubleshoot process related issues as they arise Inventory manufacturing lab supplies and ensure items are properly stocked. Participate in batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging Maintain cleanroom standards for cleanliness and order Conduct activities in support of production schedules as directed by senior staff Work effectively and efficiently in a team environment Communicate effectively with clients, supervisors, colleagues, and staff, and provide status of floor operation to leads on a regular basis Support multiple projects simultaneously Cross-train on various tasks including formulation of media and buffers, and operations to support overall success of the Biologics group. Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements Review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation Adhere to quality standards set by regulations and Abzena policies, procedures, and mission Operate to the highest ethical and moral standards Perform additional duties as assigned Qualifications 1 – 2 years cell culture experience in a GMP pharmaceutical/biotech environment role with a technical degree or equivalent combined years of both Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. A proven ability to confidently compute basic arithmetic operations. $45,000 - $60,000 a year FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
San Diego, CAManufacturing – Manufacturing /Full Time /On-Site With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. As a member of the manufacturing team at Abzena, you will be responsible for executing daily task in strict compliance with manufacturing batch records, SOP’s, and Good Manufacturing Practices (GMP). You will take ownership of the production process, facility, and environment to ensure smooth operations. Additionally, you will collaborate cross-functionally with key departments, including QA, MS&T, Facilities, and others to support successful and compliant manufacturing activities and responsibilities. Responsibilities Operate under cGMP manufacturing conditions. Ensure compliance to training on all activities prior to GMP execution. Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes. Ensures right-the-first-time performance of all process steps. Perform production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills. Escalate process related issues as they arise Inventory manufacturing lab supplies and ensure items are properly stocked. Participate in batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Maintain cleanroom standards for cleanliness and order Conduct activities in support of production schedules as directed by senior staff. Work effectively and efficiently in a team environment. Communicate effectively with clients, supervisors, colleagues, and staff. and provide status of floor operation to leads on a regular basis. Support multiple projects simultaneously. Crosstrain on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group. Perform manufacturing and process development activities for projects and products in collaboration with others. Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements. Review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including weekend work, as needed. Perform additional duties as assigned. Qualifications A minimum of 2 years of experience in a GMP pharmaceutical/biotech environment role with a technical degree or equivalent combined years of both. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Experience with aseptic handling, including BSC operations to maintain the integrity of sterile systems. Knowledge of purification using column chromatography Experience using single-use technologies, such as tube welding, tube sealing, and disposable systems A proven ability to confidently compute basic arithmetic operations. $60,000 - $80,000 a year FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Manufacturing Technician I (1st Shift) Position Summary: Work Schedule: Monday-Friday from 7:30am-4pm 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds. The Manufacturing Technician I will be responsible for conducting Good Manufacturing Practices (cGMP) manufacturing of solid oral and liquid oral pharmaceutical dosage forms for Phase I and Phase II clinical trials. Daily responsibilities will include production equipment set up, weighing of materials, sieve and blending activities, spray drying, milling, granulation, mixing, roller compaction, submitting samples, encapsulation, tableting, coating and packaging. You will be a key member of a multi-site mission to deliver unparalleled service to our clients and quality drug products to the patients. The Role: Prepare materials, equipment and manufacturing suites for production Conduct GMP manufacturing of solid oral and liquid oral dosage forms Packaging and labeling of manufactured products Pre/postproduction cleaning of equipment, supplies and manufacturing area Follow Standard Operating Procedures (SOPs) and production batch records Responsible for accurate documentation in production batch records May also assist engineering with equipment validations, preventative maintenance, and cleaning verifications Other duties as assigned The Candidate: High School Diploma or GED equivalent is required No prior experience required. Some GMP experience in pharmaceutical or medical device manufacturing a plus. Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently Pay: The anticipated salary range for this role in California is $40,000 to $46,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement. Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Several Employee Resource Groups focusing on Diversity and Inclusion. Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 152 hours of PTO + 10 paid holidays. Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic. Tuition Reimbursement – Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.