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2 weeks ago

Quality Engineer

Providien Thermoforming - San Diego, CA 92121

Description: Summary The Quality Engineer I provides quality leadership and technical support to their Value Stream Team and quality technicians within Providien Thermoforming’s manufacturing operations. Working under the guidance of the Quality Manager, this role plans, initiates, coordinates, and evaluates activities related to the application, development, and maintenance of quality tasks, processes, and systems for thermoformed products. The primary responsibility of this role is to ensure that thermoformed components and assemblies meet required quality standards, customer expectations, and applicable regulatory requirements across our medical device, aerospace, and industrial markets. Essential Job Functions Provide daily quality support to manufacturing, Engineering, including inspection, assembly, packaging and shipping operations. Investigate nonconforming products, scrap, rework, and customer complaints; identify root cause and implement effective corrective actions. Lead or Support CAPAs using tools such as 5 whys, fishbone diagrams, and process data analysis. Develop and maintain inspection plans, work instructions, acceptance criteria and manufacturing quality records. Review production documentation for completeness, accuracy and compliance with GDP. Partner with manufacturing and engineering teams on process changes, validation activities, risk assessment and FAI. Use trend data, defects rates, and quality metrics to identify recurring issues and measure improvement. Support supplier quality activities, including evaluation of supplier non-conformances and corrective actions. Participate in internal, customers and ISO 13485 audits; help prepare responses and close finding on time. Train and coach employees on quality requirements and practical application of procedures on the manufacturing floor. Develop and implement standards and methods for inspecting, testing, and evaluating thermoformed products and components. Develop and deliver quality training materials to increase awareness across the Value Stream Team. Review of customer specifications Participate in the design and process of FMEAs, Design of Experiments, PPAPs, Process/Product Capability Studies, and Product Liability Meetings. Continuously improve quality systems and processes. Other duties as required in support of the department and the company. Supervisor Responsibilities This role does not include supervisory responsibilities over other employees. The Quality Engineer provides functional quality leadership and technical guidance to quality technicians within their assigned Value Stream Team. Requirements: Qualifications To perform this role successfully, an individual must be able to satisfy each essential function listed above. The requirements below represent the knowledge, skills, and abilities needed. Reasonable accommodations may be made for individuals with disabilities. Education and Experience Bachelor’s degree in engineering or sciences, or 5+ years of experience working in a technical engineering role. Minimum of 3 years of experience in manufacturing preferred. Experience in Root Cause Analysis investigation (5 Whys, Fishbone, 8D, etc.) is preferred. Knowledge of ISO 13485:2016 and other relevant quality standards preferred Proven experience in a manufacturing quality control role. Background in medical device, aerospace, or plastics/thermoforming manufacturing industries is preferred. Certificates, Licenses, and Registrations ASQ Certified Quality Engineer (CQE) or Certified Quality Process Analyst (CQPA) preferred. Six Sigma Green Belt preferred. Language Requirements Excellent verbal and written communication skills in English are required. Mathematical Skills Basic arithmetic: add, subtract, multiply, and divide whole numbers, fractions, decimals, and percentages. Statistics: interpret and analyze numerical data using statistical methods. Basic algebra: manipulate symbols and equations to find unknown values, express relationships, and model situations. Basic geometry: understand and work with shapes, angles, lines, and planes. Basic trigonometry: understanding essential trigonometric functions and how they relate to engineering drawings and specifications. Technical Skills Proficient in MS Office Suite and SharePoint. Able to learn new business systems and associated software efficiently. Knowledge of ERP systems preferred. Excellent knowledge of blueprint reading, Geometric Dimensioning & Tolerancing (GD&T), and ASME Y14.5M. Excellent analytical, problem-solving, and attention-to-detail skills. Strong team player with the ability to collaborate across departments. Strong communication skills to effectively convey standards and procedures. Reliable and flexible to work additional hours on short notice to complete orders or special projects to meet customer or internal demands. Able to work independently with minimal supervision. Physical Demands The employee must be able to sit, stand, and walk throughout the workday. They frequently use their hands to handle objects and must communicate verbally. The role may also require reaching, crouching, stooping, and occasionally lifting objects up to 50 pounds. Specific vision abilities required include close, distance, color, and peripheral vision, depth perception, and the ability to adjust focus. Reasonable accommodation will be provided in accordance with ADA regulations. Work Environment Work is performed on the production floor of a manufacturing facility. Conditions may include exposure to machinery, noise, temperature variation, and other physical workplace factors. A culture of safety, teamwork, and continuous improvement is expected. Environmental Policy Providien Thermoforming is committed to minimizing the environmental impact of its operations, activities, and products. We comply with all applicable environmental regulations, work to prevent pollution, and continuously improve our environmental performance. Our Environmental Management System provides a framework for setting and reviewing environmental objectives and targets. Personal Protective Equipment Requirements Safety toe footwear meeting ASTM F-2412-2005, ANSI Z41-1999, or ANSI Z41-1991 standards in designated areas. ANSI Z87.1 safety-rated clear glasses in designated areas. Hearing protection in designated areas. Compliance with applicable Job Safety Analysis (JSA) requirements. Travel Approximately 15% travel is expected for this role. Providien Thermoforming does not accept unsolicited resumes or candidate submissions from external recruiters or staffing agencies for this position. Any resumes submitted without a signed agreement in place will be considered the property of Providien Thermoforming, and no placement fee will be paid.

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2 weeks ago

Manufacturing Associate I-II – Contractor

Artiva Biotherapeutics - San Diego, CA 92121

About Artiva: We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell-killing properties of NK cells, when combined with mAbs for targeting, create an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com Join Artiva Biotherapeutics in San Diego and work directly on the manufacturing floor to produce our innovative, off-the-shelf cell therapies in a state-of-the-art cGMP facility. Apply your expertise across cell culture, aseptic processing, harvest and fill-finish, playing a direct role in advancing therapies for patients with autoimmune diseases. This is a contract-only position. Summary The successful candidate will play a key role in the manufacturing of cell therapies internally at Artiva. He/ she will execute hands-on manufacturing processes to deliver new revolutionary therapeutics. The ideal candidate will demonstrate in-depth knowledge of cGMP compliance, strong hands-on laboratory skills and work in a high-performing team of manufacturing associates. Key Responsibilities Execute GMO manufacturing operations including cell expansion, harvest, and fill-finish. Perform Aseptic Process Validation and participate in annual aseptic qualification. Follow cGMP standards and procedures to maintain compliance. Support development of batch records, workflows, and SOPs in accordance with regulatory and GMP requirements. Apply cell culture expertise to media/buffer preparation, cell passaging, bioreactor production, and harvesting. Lead after-action reviews to improve operational efficiency and KPIs, identify process gaps/risks, and implement sustainable improvements. Support equipment and process change controls through implementation. Work in Grade B and Grade C cleanroom environments. Perform hands-on manufacturing operations directly on the floor. Qualifications Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience. Minimum 1 year of cGMP biologics or cell culture manufacturing experience; biotech or cell therapy experience preferred. Preferred experience with: Aseptic gowning and ISO 7 cleanroom manufacturing Cell counting platforms Cell culture and expansion using bag systems and single-use large-scale bioreactors; Sartorius experience a plus Lentiviral transduction Automated and manual cell harvesting/washing; LOVO experience a plus Cell selection/depletion using Miltenyi CliniMACS Prodigy Fill-finish and cryopreservation in bags and vials; M1 filler and AT-vial experience a plus Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. Innovative, adaptable, and able to apply best practices in a small, growing environment. Self-motivated with strong ownership, organizational skills, and the ability to prioritize and deliver results on time. Working Conditions and Physical Requirements Work with cells and cell lines of human origin. Ability to stand and work gowned for prolonged periods. NO AGENCIES PLEASE In addition to a great culture, we offer: A beautiful facility An entrepreneurial, highly collaborative, and innovative environment If all this speaks to you, come join us on our journey! Base Salary: $36-$50 per hour. Exact compensation may vary based on level, skills, and experience.

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2 weeks ago

Quality Management Systems Manager

Nordic Naturals - Vista, CA

Location - Vista, CA - Hybrid Salary - 109K - 129K POSITION SUMMARY The Quality Management Systems (QMS) Manager is responsible for overseeing, standardizing, and advancing Nordic Naturals' quality management systems across headquarters and manufacturing facilities (Watsonville and Vista). Reporting directly to the Director of Quality, this role spearheads the development and implementation of an integrated electronic Quality Management System (eQMS). The QMS Manager oversees core compliance functions—including Document Control, Change Control, Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), Deviations, and Internal/External Quality Audits—ensuring rigorous cGMP compliance under 21 CFR Part 111 and 21 CFR Part 11 while driving a culture of continuous quality improvement. Reasonable Accommodations Statement To accomplish this job successfully, this individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. ESSENTIAL FUNCTIONS eQMS Implementation & Governance: Lead the evaluation, integration, and administrative oversight of a unified electronic Quality Management System (eQMS) bridging multi-site operations (HQ, Vista, and warehouse locations). Document & Change Control Management: Oversee the Document Control team and manage Change Control (CCO/CCR) processes to ensure all Standard Operating Procedures (SOPs), Master Formulas, and Packaging Specifications strictly adhere to cGMP standards. CAPA & Non-Conformance Oversight: Direct cross-functional Non-Conformance Report (NCR) and Corrective and Preventive Action (CAPA) investigations and execution through an eQMS or other existing forums, ensuring timely execution of investigation and implementation steps. Audit Program Leadership: Manage the internal cGMP audit schedule across production, compounding, packaging, and laboratory areas. May need to be present for as a quality contact during FDA, NSF, and third-party regulatory audits. Cross-Functional Collaboration: Partner closely with Manufacturing, Operations, Product Development, and Technical Engineering teams to streamline quality workflows, eliminate production bottlenecks, and support new product launches and plant trials. Metrics & Quality Reporting: Establish, track, and report key quality performance indicators (KPIs) and monthly metrics (investigation cycle times, CAPA resolution rates, SOP gap closures) to the Director of Quality and leadership. Team Leadership & Development: Supervise, mentor, and evaluate direct reports within Quality Systems and Document Control, establishing clear accountabilities and professional development pathways. POSITION QUALIFICATIONS Competency Statements Leadership: Ability to influence cross-functional teams, drive accountability, and foster a collaborative, compliance-minded quality culture. Problem Solving & RCA: Advanced analytical capabilities in root cause investigation (RCA) and risk mitigation (FMEA, HACCP). Detail Oriented: Exceptional precision in evaluating complex documentation, batch records, investigations, and regulatory standards. Communication: Outstanding written and verbal communication skills for presenting quality findings and leading regulatory audit defense. Strategic Thinking: Ability to align QMS objectives with long-term corporate growth and operational scale. SKILLS & ABILITIES Education: Bachelor's degree in chemistry, Biology, Bioengineering, Quality Systems, or related scientific discipline required. Master's degree, PCQI or ASQ certification preferred. Experience: 5+ years of direct experience in Quality Assurance or Quality Engineering within a cGMP dietary supplement, food, or pharmaceutical manufacturing environment, with 3+ years in a supervisory/management capacity. Computer Skills: High proficiency with Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) software (e.g., SAP). Working knowledge with PLM/eQMS software platforms, Filemaker, Smartsheet. Advanced knowledge of Microsoft Office Suite (particularly Excel for data tracking, Word for SOP drafting, and PowerPoint for training delivery).

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2 weeks ago

Quality Assurance Associate II

Argonaut Manufacturing Services - Carlsbad, CA 92010

Corporate Overview Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence Benefits and Pay Range At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy: Medical, Dental, and Vision Insurance Company-Paid Life Insurance (1x Annual Salary) Voluntary Life Insurance Options Short-Term and Long-Term Disability Insurance Flexible Spending Account (FSA)Health Savings Account (HSA) 401(k) Retirement Plan with Company Matching 10 Days of Paid Time Off (PTO) 10 Paid Holidays Annually The pay range for this position is $74,000 - $80,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications. Position Overview The purpose of this position is to perform tasks pertaining to assurance compliance with quality requirements, including leading quality investigations, managing client complaints, and reviewing production batch records and associated documentation required to release a production lot. This role also supports the investigation and resolution of customer complaints, deviations, and internal non-conformance events, helping drive CAPA and continuous improvement efforts. This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Hours are 9:00 am - 5:30 pm with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance. Responsibilities and Duties Review production records and associated documentation for lot disposition Prepare Certificate of Compliance (COC) and review Certificate of Analysis (COA), as required Perform line clearance functions for cGMP processes Support manufacturing operations and staff to address product quality and compliance issues, as they arise Initiate, lead and/or assist investigations into quality issues such as complaints, Corrective and Preventive Actions (CAPAs), and non-conformances Perform visual inspection of finished product Manage client complaints Oversee facility/cleanroom cleaners to ensure they are fully trained and have documented training for current Argonaut/Aluris procedures, have current unexpired cleaning forms available, and maintain annual gowning requalifications as applicable Perform facility walkthroughs to ensure cleanrooms, laboratories, warehouse, etc. remain in compliance Requirements and Qualifications Bachelor's degree in Life Sciences discipline or equivalent is preferred Minimum four (4) years of relevant experience Must be able to effectively communicate within the department and cross-functionally with other divisions High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction Experience with MasterControl and NetSuite a plus Superior attention to detail, organizational skills, and the ability to multi-task in a time- line driven environment Experience working in the life science and/or pharmaceutical manufacturing industry Proven problem-solving skills Excellent oral and written communication skills, and listening skills Working knowledge of cGMP regulations, 21 CFR 820, ISO 13485, and good documentation practices Ability to make decisions regarding quality of product and material Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

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2 weeks ago

Machine Operator

PrideStaff Carlsbad - Escondido, CA 92029

Overview We are seeking a dedicated and skilled Machine Operator to join our dynamic team in Carlsbad, CA. In this role, you will play a crucial part in our production process, ensuring that our machinery operates smoothly and efficiently. If you have a passion for precision and a knack for troubleshooting, we want to hear from you! Responsibilities Operate and monitor machinery to ensure optimal performance and safety. Perform routine maintenance and troubleshooting on equipment. Read and interpret blueprints and technical drawings. Maintain accurate production records and reports. Collaborate with team members to meet production goals and deadlines. Adhere to all safety protocols and regulations. Assist in training new operators as needed. Identify and report any issues or malfunctions to management. Qualifications High school diploma or equivalent; technical certification is a plus. Proven experience as a machine operator or similar role. Strong mechanical aptitude and problem-solving skills. Ability to read and interpret technical documents. Familiarity with safety standards and practices in a manufacturing environment. Excellent attention to detail and a commitment to quality. Ability to work independently and as part of a team. Flexibility to work various shifts as needed.

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2 weeks ago

QA Production Technician

Revelyst - Carlsbad, CA

Job Description JOB OVERVIEW We are seeking an organized, detail-oriented Quality Assurance Production Technician to join our QA team. In this role, you will execute daily inspection and test activities for our hardware products, ensuring every device leaving the production line meets our standards for quality and reliability. This position reports to the QA Supervisor. Key Responsibilities Coordinate activities to meet daily throughput targets Partner with the Production Manager to ensure adequate resources are available for hit testing Participate in morning stand-ups and production meetings; report daily throughput along with any problems, impediments, or blockers Test devices coming off the production line, including: Visual inspection and classification of cosmetic defects Functional testing of electronic systems Execution of test scripts, ensuring related documentation and workflow are completed correctly Perform software testing as needed Execute research tests and experiments; organize, analyze, and present the results Support all company sales and promotional efforts as required. Qualifications Required Prior experience in a quality assurance, manufacturing, or production environment Strong written and verbal communication skills Proficiency with Microsoft Excel and general PC applications Comfort following and improving detailed written test procedures Preferred Experience with consumer electronics or precision hardware manufacturing Experience with inspection or production data collection tools Physical Requirements Standing for extended periods Lifting up to 30lbs Close visual inspection work Pay Range: Hourly Rate: $20.00 - $23.50 The actual annual salary offered to a candidate will be based on variables including experience, geographic location, education, and skills/achievements, and will be mutually agreed upon at the time of offer. We offer a highly competitive salary, comprehensive benefits including: medical and dental, vision, disability and life insurance, 401K, PTO, paid holidays, gear discounts and the ability to add value to an exciting mission! Our Postings are not intended for distribution to or use in any jurisdiction, country or territory where such distribution or use would violate local law or would subject us to any regulations in another jurisdiction, country or territory. We reserve the right to limit our Postings in any jurisdiction, country or territory. Equal Opportunity Employer Protected Veteran/Disabled

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2 weeks ago

Quality Assurance Hit Tester II

Revelyst - Carlsbad, CA

Job Description JOB OVERVIEW FSS QA Hit Tester- Assists for all production, RMA and Marketing devices to ensure that quality products both functionally & cosmetically are completed per schedule in the most efficient manner possible. Completes checklist process for each device and updates the process per quality feedback from our customers. Communicates & coordinates with QA Supervisor quality information with Production & Engineering personnel for failure & root cause analysis for product improvements. This position reports to the QA Hit Tester, Supervisor. As the QA Hit Tester, you will have an opportunity to: Coordinate Quality Assurance Tecnicians activities to make sure it meets daily throughput needs. Coordinate with Production Manager to ensure available resources for hit testing. Participate in Morning stand-up / production meetings, report daily throughput. Report any problems, impediments, or blockers. Test devices coming out of production line, including: Visual inspection and classified cosmetic defects; Functional test of electronic functions; Hit testing using several golf clubs, applying typical golf swings Follow test scripts and esure related documentation and workflow is completed correctly. Perform software testing as needed. Execute research tests and experiments; organize and present results. Support all company information technologies efforts as required Support all company sales and promotional efforts as required. Continues to build knowledge of the organization, processes, and customers You have the following qualifications that are necessary for someone to fill this position: Excellent communication skills Organized Experienced golfer PC Skills Pay Range: Hourly Rate: $25.00 - $28.50 The actual annual salary offered to a candidate will be based on variables including experience, geographic location, education, and skills/achievements, and will be mutually agreed upon at the time of offer. We offer a highly competitive salary, comprehensive benefits including: medical and dental, vision, disability and life insurance, 401K, PTO, paid holidays, gear discounts and the ability to add value to an exciting mission! Our Postings are not intended for distribution to or use in any jurisdiction, country or territory where such distribution or use would violate local law or would subject us to any regulations in another jurisdiction, country or territory. We reserve the right to limit our Postings in any jurisdiction, country or territory. Equal Opportunity Employer Protected Veteran/Disabled

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2 weeks ago

QC Analyst I

Nucleus Biologics - San Diego, CA 92127

About Nucleus Biologics: At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations. Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability. JOB SUMMARY: Nucleus Biologics™, The Cell Performance Company™, is the leading provider of custom cell-growth media, tools, and technologies for cell and gene therapy. Our mission is to speed the time from scientific discovery to cure by delivering innovative, transparent and cGMP products and services with the goal of disrupting the market and eliminating antiquated practices and products. We have multiple state-of-the-art facilities where we manufacture our products. The QC Analyst I is responsible for executing routine quality control activities, including in-house environmental monitoring (static and dynamic) and water testing, in-process quality monitoring during manufacturing events and incoming quality inspections. This role ensures compliance with applicable regulations and internal quality standards while supporting laboratory operations, data entry and trending, and inventory management. The QC Analyst I will also contribute to maintaining an efficient and compliant QC laboratory through the execution of daily and weekly tasks. RESPONSIBILITIES: Environmental Monitoring & Water Testing Perform routine environmental monitoring of classified and non-classified areas (air, surface, and personnel). Perform personnel and environment monitoring during manufacturing runs. Conduct high-purity water testing in accordance with USP <645> and other applicable standards. Quality Control Testing Conduct testing of raw materials, in-process samples, and finished products to verify compliance with product specifications and regulatory requirements. Testing may include: FTIR, Raman (Identity Testing); training provided USP compendial released testing (i.e. pH, Osmolality, Density, and Appearance) Support investigations of deviations, out-of-specification (OOS) results, and non-conformances, including documenting findings in accordance with established procedures. Support internal quality metrics reporting and participate in process improvement activities. Complete, archive and maintain raw material specification packets Laboratory Operations & Compliance May operate and/or assist with maintaining laboratory equipment such as autoclaves, incubators, microscopes, and endotoxin readers. Maintain accurate, complete, and compliant documentation of all QC activities, testing, analyses, and laboratory activities. May assist with preparing and reviewing SOPs, test methods, protocols, and reports. Support internal and external audits and follow laboratory practices aligned with cGMP and ISO 9001/13485 requirements. Assist with maintaining optimal inventory levels of reagents, media, and consumables. Ensure cleanliness, organization, and operational readiness of the QC laboratory. Support qualification and preventive maintenance activities for lab equipment. REQUIREMENTS: Bachelor’s degree in Chemistry, Microbiology, Biology, or a related field is preferred. A combination of education and/or relevant job experience may be considered. 1-3 years of experience in a QC laboratory within the pharmaceutical, biotechnology, or related regulated industry. Relevant cGMP laboratory internships may be considered. Cleanroom and gowning experience in ISO Class 7/8 areas required Experience with environmental/personnel monitoring, water testing, or microbiological/chemical testing methodologies preferred; training provided. Familiarity with USP and cGMP requirements; exposure to ISO 9001/13485 a plus. Strong organizational skills with attention to detail and the ability to manage multiple tasks. Proficiency in Microsoft Excel for data entry and basic trending; experience with LIMS or similar QC systems a plus. Excellent communication and documentation skills, with the ability to work cross-functionally in a fast-paced environment. ADDITIONAL SKILLS: · Ability to prioritize daily and weekly tasks and meet assigned deadlines · Ability to communicate effectively both orally and in writing and to establish and maintain productive working relationships · Strong attention to detail and process mindset · Ability to follow established procedures and escalate issues appropriately · Excellent verbal and written communication skills. · Familiarity with statistical process control methods a plus. PHYSICAL REQUIREMENTS: · Ability to hear and speak to employees and external associates on the phone and in person. · Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision) · Ability to wear full cleanroom gowning in accordance with ISO 7 and 8 requirements · Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions TRAVEL REQUIREMENTS: · None NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time. The pay range for this role is: 70,000 - 80,000 USD per year(10908)

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2 weeks ago

Sr / Principal Validation Engineer

Bachem - Vista, CA 92081

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com. A brief overview The Sr. / Principal Validation Engineer fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations What you will do Develop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports Perform, coordinate, execute and analyze cleaning recovery studies. Lead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables. Provide qualification / validation guidance and strategy during project planning and development phases. Train, coach and mentor Quality Engineer I and II. Write validation protocols and final reports, test methods, standard operating procedures, and technical reports. Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports. Independently conduct and document investigations related to validation studies. Based on validation studies, evaluate and make recommendations for improvements to operations, processes and methods. Accountable for the accuracy and validity of testing results Support and assist with l inspections and audits. Perform other related duties as assigned. Plan and perform required periodic re-validation / re-qualification activities Work and communicate with different associates within the company to ensure timely completion of assigned tasks and projects. Adherence to cGMP and safety procedures and contribute to GMP systems improvements. Qualifications Bachelor's degree in science discipline (chemistry, biochemistry, organic chemistry, biology, microbiology, chemical engineering or equivalent) Master’s degree in science related field (engineering, chemistry, biology or equivalent). (preferred) 5+ years of Commissioning, Qualification and Validation (CQV) experience in a GMP/GDP environment Experience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports Experience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units Experience with planning and execution of cleaning validation of production lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations (preferred) Experience with developing coupon spike and recovery studies for cleaning validation Experience with Lean Six Sigma methods: root cause analysis, failure mode analysis and analyzing / organizing complex technical problems Understanding of cleaning validation requirements for pharmaceutical industry Knowledge of and ability to perform MAC calculation for APIs Understanding of GMP for Active Pharmaceutical Ingredients per ICH Q7. Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations they undergo, including use of chemicals and their interactions, danger signs, production techniques, and disposal methods. General lab instrumentation knowledge and operation experience. Capable of working methodically and adhering to rules and regulations. Base salary range: Sr Engineer: $103,939 - $142,916 Principal Engineer: $120,875 - $166,204 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation. Please note: unsolicited resumes from recruitment agencies will not be considered. Nearest Major Market: San Diego

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2 weeks ago

Quality Control Technician

Bachem - Vista, CA 92081

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com. A brief overview The Quality Control Technician supports day-to-day Quality Control operations by coordinating samples and documentation, maintaining laboratory records and materials, entering and trending data, and assisting with activities that help ensure compliance with current Good Manufacturing Practice (cGMP), internal procedures, and applicable safety requirements. Expected assignment duration: 6 months What you will do Receive, log, label, route, and track raw material, in-process, stability, and finished-product samples and associated documentation. Maintain QC sample records, stability schedules, trackers, dashboards, and other controlled laboratory data; enter and trend/graph data as assigned. Archive, retrieve, organize, and reconcile analytical documentation and laboratory records in accordance with applicable procedures. Coordinate external testing, including sample preparation, shipment documentation, status follow-up, and filing of results. Manage reference materials, standards, reagents, retained samples, and laboratory consumables, including inventory monitoring and ordering support. Support peptide and material disposition activities by compiling required records, performing approved calculations, and routing documentation for review. Support generation, revision, review routing, and maintenance of QC documentation, including SOPs, forms, training records, deviations, change controls, and out-of-specification documentation, as assigned. Coordinate sampling and testing activities with Quality Control, Quality Assurance, Production, and other departments; proactively communicate status and potential issues. Ensure assigned QC equipment and work areas are maintained in a clean and organized state; assist with equipment records, service coordination, and calibration status tracking. Support special projects, regulatory or customer requests, and continuous-improvement activities, including QC dashboard development. Qualifications Associate’s degree in relevant scientific field or 2 years of relevant college coursework while working toward completion of Bachelor's degree Experience in Quality Control, pharmaceutical, biotechnology, chemical, or other regulated laboratory environment (preferred) Experience with laboratory documentation, sample coordination, inventory, data entry, or document control (preferred) Previous experience with peptides or pharmaceutical ingredients (preferred) Basic understanding of cGMP and good documentation practices, or the ability to learn and consistently apply these requirements. Excellent written and oral communication skills. Basic computer proficiency, including Microsoft Word, Excel, and PowerPoint. Ability to effectively organize, prioritize, and multitask in a fast-paced, deadline-driven environment. Ability to communicate proactively and in a solutions-focused manner, including keeping management aware of potential issues. Detail-oriented approach with strong documentation, troubleshooting, and problem-solving skills. Ability to work independently, manage time effectively, and function well in a team environment. Ability to perform routine mathematical calculations and accurately enter, review, and trend data. Ability to coordinate activities collaboratively with Quality Control, Quality Assurance, Production, and external laboratories. Flexibility to work hours based on business needs, which may include some nights and occasional weekends. Base Houlry Pay Range: $24.91 - $34.26 Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation. Please note: unsolicited resumes from recruitment agencies will not be considered. Nearest Major Market: San Diego

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2 weeks ago

Water Utility Worker

Rancho Pauma Mutual Water Company - Pauma Valley, CA

*About us* Located at the base of Palomar Mountain, Rancho Pauma Mutual Water Company is a mutual water company in Pauma Valley, CA that provides drinking and agricultural groundwater to our customers. We are a small but mighty professional water company and our goal is to provide safe, clean drinking water to our customers and make Rancho Pauma Mutual Water Company a wonderful place to work. Rancho Pauma Mutual Water Company is hiring a Water Utility Worker. We are a small but efficient Water Company and seek to hire operators that are team players. The Company is looking for operators that are willing to cross train and complement our hard working team. Under general supervision, performs a variety of semi-skilled to skilled heavy manual work, alone or as a member of a crew, in the construction, maintenance, and repair of water distribution and treatment systems or related utility functions. This position requires to work stand-by on a rotational basis and report to work on a callback basis as needed within a designated time frame. This is a non-exempt, hourly position that works in direct contact with the Utility Department Supervisor and the general public in the scope of his or her duties. Interested candidates should have the following: SWRCB Water Treatment Operator Grade 1 Certification SWRCB Water Distribution Operator Grade 1 Certification Possession of a valid Class C driver’s license Wage is dependent on qualifications and experience. This is a full time position and includes competitive salary, medical insurance, standard holidays, 401 (k) Profit Sharing Plan, Group Term Life Insurance, Personal Time Off/ Vacation and Sick leave and a great work environment. Please visit our Employment page on our website at www.ranchopaumamwc.com to view the detailed job description and application. Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required for this role. Duties, responsibilities, and activities may change or be assigned at any time with or without notice. Job Type: Full-time Pay: From $28.00 per hour Benefits: * 401(k) * Health insurance * Paid time off People with a criminal record are encouraged to apply Experience: * related: 1 year (Required) License/Certification: * Water Distribution Operator Grade 1 Certification (Required) * Water Treatment Operator Grade 1 Certification (Required) Work Location: In person

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2 weeks ago

Landscape Irrigation Pipefitter 4th Yr Apprentice (90 A.Y4)

Brightview - San Diego, CA 92130

Location: San Diego, CA, United States Date Posted: Sep 25, 2026 Req number: JR16675 Job Type: Regular Full Time Pay Range: Prevailing wage rates Description The Best Teams are Created and Maintained Here. Job Summary The BVG Land/Irrigation Fitter 4Yr position serves as an advanced irrigation pipefitter. Duties and Responsibilities: Perform various irrigation pipefitter duties. Education and Experience: Minimum of 3 years’ experience Must be able to fit pipe of ½” through 4” Must be able to take directions and complete tasks Practice workplace safety Physical Demands/Requirements: Ability to lift and carry tools, equipment, materials weighing up to 50 lbs. Be at least 18 years old (21 if operating company provided vehicles) Possess strong stamina and have the ability to work outdoors in various weather conditions including extreme heat and cold. Able to safely operate landscaping equipment (e.g., mowers, trimmers, blowers, edgers). Able to bend, stoop, kneel, twist, stand, walk continuously throughout the day and perform repetitive motions for extended periods. Able to perform manual labor using a variety of hand tools (e.g. shovels, rakes) You are able to wear appropriate personal protective equipment (e.g., safety shoes, high-visibility clothing, hand protection, eye protection, hearing protection, head protection) Landscapers who will be operating a BrightView fleet vehicle are required to have a valid driver’s license and meet company standards as it relates motor vehicle performance identified on a state issued motor vehicle record check. Ability to work flexible hours, including weekends or holidays if needed. Ability to maintain, in your possession at all times, required medications to address any known allergic reactions should they occur. Work Environment: Ability to work outdoors/indoors in moderate to extreme weather conditions (e.g., temperatures more than 100°F, temperatures below 32°F, various levels of humidity) Ability to work in direct sunlight for extended periods of time. Work outdoors near automotive traffic, bodies of water, fumes, dust, mechanical and/or electrical hazards. Ability to work in environments where extended periods of loud noise are present. Ability to work in environments where exposure to allergens such as pollen and rag weed, insects such as bees and spiders and reptiles such as lizards and snakes. BrightView Landscapes, LLC is an Equal Opportunity and E-Verify Employer. This job description is subject to change at any time. Compensation Pay Range: Prevailing wage rates BrightView offers a suite or health, wellness, and financial benefits to full-time team members. Benefits offerings for full-time team members include medical, dental, and vision insurance, ancillary and voluntary products, a 401k savings plan with employer contributions, and 6 to 9 company paid holidays per year. Employees may also be eligible to receive paid time off for vacation and/or sick leave, tuition reimbursement, and/or potential variable pay opportunities based on position and performance. A detailed benefits package will be provided during the interview process. It’s Not Just a Team. It’s One BrightView.

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