GMP Jobs in California

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Engineering Technician- Temp Contract

10x Genomics

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 Engineer

Katalyst Healthcares and Lifesciences

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.

Validation Engineer

ACL Digital

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)

Katalyst Healthcares and Lifesciences

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

Engineer

Katalyst Healthcares and Lifesciences

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

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical

Process Engineer II

Gilead Sciences, Inc.

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

DeltaV Automation Engineer

Fynbosys Inc

Remote or Muskegon, Michigan, USA

Contract

Title : Sr/Lead DeltaV Automation Engineer Location - Muskegon, MI (Onsite) Cognizant JD : This is a remote position open to any qualified applicant in the United States.We are open to considering remote candidates who are willing to travel frequently to client sites at Muskegon MI. Travel Requirement : The travel requirements include an initial three weeks to overlap with another senior engineer. Subsequently, the schedule is anticipated to be two weeks of travel to Muskegon MI followed by thr

Senior Director IT Quality Assurance & Compliance

Regeneron Pharmaceutical

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 Engineer

Amgen Inc

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 Engineer

Amgen Inc

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

Director, Engineering - Drug Product Commercialization

Merck & Company Inc

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 Therapy

Gilead Sciences, Inc.

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 Support

Merck & Company Inc

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 Systems

Katalyst Healthcares and Lifesciences

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 - Firmware

Penumbra Inc

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)

Pace® Life Sciences

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 III

HAYS

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 Engineering

Amgen Inc

Remote or 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

Automation Engineer

Katalyst Healthcares and Lifesciences

Thousand Oaks, California, USA

Full-time

Responsibilities: Manage day-to-day support of ATO Drug substance operations. Represent plant automation team in Area WCTs. Lead a team of Automation engineers responsible to support and deliver on complex capital construction projects including Global Lifecycle Asset Management (GLAM) projects. Lead the direct reports including External Workers (EWs), onboarding the EWs, and ensuring the direct reports' adherence to Client training requirements. Represent Plant Automation team during the develo