gmp Jobs in california

21 - 40 of 49 Jobs

Component Engineer - Validation (IQ/OQ/PQ)Job Title - Component Engineer - Validation (IQ/OQ/PQ)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards. Roles & Responsibilities: Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports.

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Thousand Oaks, California, USA

Full-time

Responsibilities: Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines. Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment. Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equi

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Job Description: The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execution, and continuous improvement of validation processes across multiple sites, while supporting audits, risk assessments, and global quality initiatives. Responsibilities: Interpret and implement validation requirements based on FDA regulations, corporate stan

Engineering Technician- Temp ContractJob Title - Engineering Technician- Temp Contract

10x GenomicsCompany Name - 10x Genomics

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Pleasanton, California, USA

Full-time

About the role: We are seeking an organized, detail-oriented, problem-solving individual to join our Life Cycle Engineering team. The successful candidate will have strong attention to detail, great communication skills, ability to prioritize a variety of tasks, and the ability to work independently in a fast-paced environment. The Engineering Technician supports engineers so they can keep developing our manufacturing workcells and equipment. Our products have allowed researchers to study biolo

Process EngineerJob Title - Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Responsibilities: Senior Process Engineer responsible for tech transfers within the manufacturing team. Support GMP-related activities. Experience in tech transfer and project management. Strong technical skills, including report writing and problem-solving. Excellent communication skills, with the ability to clearly relay technical information. Cell Therapy (CAR-T) experience (preferred). Willingness to travel (approximately 25%). t least 5 years of relevant experience.

EngineerJob Title - Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Los Angeles, California, USA

Full-time

Roles & Responsibilities: 4-6 years Minimum bachelor's or master's degree in a health-care related field Strong knowledge of GMP (Good Manufacturing Practices) and ISO 13485 standards, along with regulatory affairs. Strong creative, analytical, and problem-solving skills. Proficient in interpreting data and compiling detailed reports. Expertise in Design Quality, Good Manufacturing Practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, and Manufacturing Processes. Expertis

Validation EngineerJob Title - Validation Engineer

ACL DigitalCompany Name - ACL Digital

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California, USA

Full-time

Job Title: Validation Engineer Location: La Verne, CA Duration: 12+ Months Description: Independent engineer who have in depth knowledge about validation lifecycle management and be able to write VMP, protocols and corresponding summary reports ble to execute test protocols independently and resolve deviation and collaborate with engineering team, business process owner and QA to make changes if necessary. Able to investigate failure and write deviation and change control records. Experienc

Sr. Validation Engineer (CSV)Job Title - Sr. Validation Engineer (CSV)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia

Senior Director IT Quality Assurance & ComplianceJob Title - Senior Director IT Quality Assurance & Compliance

Regeneron PharmaceuticalCompany Name - Regeneron Pharmaceutical

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Remote or Sleepy Hollow, New York, USA

Full-time

As a Senior Director of IT, Quality Assurance and Compliance, you will lead a team of those managing 20 to 30 members The focus is to provide leadership, coaching, and technical support to the IT QA & Compliance Management Team. This role is an on-site position 4 days/week at our Sleepy Hollow, NY or Warren, NJ office. There will be occasional travel to other sites in the Rensselaer, NY area. If eligible, we can offer relocation benefits. We are unable to offer a fully remote option. A typical

Senior EngineerJob Title - Senior Engineer

Amgen IncCompany Name - Amgen Inc

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Thousand Oaks, California, USA

Full-time

Career Category Engineering Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients ea

Senior Process Development EngineerJob Title - Senior Process Development Engineer

Amgen IncCompany Name - Amgen Inc

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Thousand Oaks, California, USA

Full-time

Director, Engineering - Drug Product CommercializationJob Title - Director, Engineering - Drug Product Commercialization

Merck & Company IncCompany Name - Merck & Company Inc

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Remote or West Point, Pennsylvania, USA

Full-time

Job Description Job Description: Director, Center of Excellence for Sterile Drug Product Commercialization Overview We are seeking a dynamic and experienced leader for the role of Director within our Center of Excellence (CoE) for Sterile Drug Product Commercialization. Sterile Drug Product Commercialization is the Company's Manufacturing Division business unit responsible for late-stage development of vaccines, biologics and sterile pharmaceutical drug products. Sterile Drug Product Commerci

Sr Associate Scientist, Data Analytics -Cell TherapyJob Title - Sr Associate Scientist, Data Analytics -Cell Therapy

Gilead Sciences, Inc.Company Name - Gilead Sciences, Inc.

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Santa Monica, California, USA

Full-time

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great l

Sr. Spclst , Technical SupportJob Title - Sr. Spclst , Technical Support

Merck & Company IncCompany Name - Merck & Company Inc

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Remote or Rahway, New Jersey, USA

Full-time

Job Description Business Technology Partner Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We partner internationally to deliver the services and solutions that help development scientists to be more productive and enable innovation. The BTP ensures translation of business strategy to IT strategy, relevant communication to business and IT functions, and develop strategic digital roadmaps, and lead delivery of ca

Systems Administrator / Technical Lead - Process Control SystemsJob Title - Systems Administrator / Technical Lead - Process Control Systems

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Foster City, California, USA

Full-time

Job Summary: We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates

Principal R&D Engineer - FirmwareJob Title - Principal R&D Engineer - Firmware

Penumbra IncCompany Name - Penumbra Inc

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Alameda, California, USA

Full-time

General Summary The Principal Research and Development Engineer/Firmware is reserved for senior engineering personnel with outstanding scientific and technical knowledge. Provide leadership in engineering, design, and development of new products or changes to existing products, processes, and equipment. This role will require hands-on individual contributions and the desire to train, develop, and manage junior to mid-level engineers, as well as provide scientific knowledge to a multidisciplinar

Commercial Operations Sales Analytics (Remote)Job Title - Commercial Operations Sales Analytics (Remote)

Pace&reg; Life SciencesCompany Name - Pace&reg; Life Sciences

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Remote or Oakdale, Minnesota, USA

Full-time

About Us Pace Life Sciences Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations. Job Description Commercial Operations - Sales Analytics We are looking for a self-starter, with strong dat

IT Engineering Specialist IIIJob Title - IT Engineering Specialist III

HAYSCompany Name - HAYS

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San Francisco, California, USA

Contract

IT Engineering Specialist - Contract - San Francisco, CA - $73.43 - $73.43/hr. The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position. Applicants must be legally authorized to work in the United States. Visa sponsorship is not available. Our c

Principal Engineer - Thermal EngineeringJob Title - Principal Engineer - Thermal Engineering

Amgen IncCompany Name - Amgen Inc

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Remote or Thousand Oaks, California, USA

Full-time

Business Analyst - Data and AnalyticsJob Title - Business Analyst - Data and Analytics

Advanced Software TalentCompany Name - Advanced Software Talent

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South San Francisco, California, USA

Contract

This is a hybrid contract for candidates that are located in Northern California and 100 % remote for candidates outside the area. Direct W2 contractors only! No 3rd party agencies! We are not able to sponsor any H1B Visa! Description BA, Clinical Stage Cell Therapy Process & Analytical Development - Data and Analytics The Business Analyst (BA) is a self-motivated expert in business analysis who is passionate about improving healthcare. They are flexible and dedicated to providing value to patie