Cell Therapy CQV Engineer — GMP Validation Lead
Katalyst CRO
Katalyst CRO in New Jersey seeks a senior CQV professional to support commissioning, qualification and validation for our cell therapy manufacturing plant, ensuring compliant operations and data integrity. You will lead CQV protocols, summary reports, CAPAs and investigations, mentor junior staff, and coordinate with QA, manufacturing and regulatory teams for audits and product release. Candidates should have 8+ years of CQV experience in aseptic cell therapy environments, with strong #J-18808-Ljbffr Katalyst CRO
- ...Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This... ...requirements. This role will require CQV experience, represent CQV work... ...Bachelor's Degree in Science, Engineering or equivalent technical discipline...SuggestedWork experience placementShift work
$146.41k - $192.16k
Legend Biotech in Bridgewater, NJ, seeks a Sr. Manager, QC Microbiology to lead the QC microbiology labs supporting cell therapy manufacturing. You will hire, develop and manage staff, review test data, and drive microbiology procedures and investigations. The role demands...Suggested- ...Operations team in Raritan, NJ. This role supports the production of a personalized cell therapy in a sterile cGMP environment. You will work in a cross-functional setting with Manufacturing, Engineering, and Quality, performing unit operations like cell culture, purification,...SuggestedShift workDay shift
$88k - $134k
...the consulting, architecture, engineering, project controls,... ...construction management, and CQV of technically complex facilities... ...commissioning, qualification, validation, consulting, etc.) as developed... ..., and PQ forms/protocols for GMP Utilities, Equipment, Systems...SuggestedFlexible hoursNight shift- ...Piper Companies is currently looking for an experienced (CQV) Validation Engineer in Raritan, NJ to work for an innovative and growing pharmaceutical... ...a minimum of 30 days from the posting date. Keywords GMP, Pharmaceutical Manufacturing, Equipment Qualification,...Suggested
- ...Key Responsibilities CQV Execution & Safety - Perform... ...Commissioning, Qualification, and Validation (CQV) activities with a... ...Bachelor’s degree (BS/BA) in Engineering, Chemistry, or Life Sciences... ...- Essential experience in a GMP (Good Manufacturing Practice)...For contractorsWorldwide
$72k - $116k
...Description Celltrion is a leading biopharmaceutical company that... ...patients’ access to advanced therapies. We have been at the forefront... ...support multiple site-wide Engineering and Maintenance groups in the... ...maintenance package for changes to GMP equipment and systems....Contract workTemporary workWork experience placementLocal areaRelocationRelocation packageShift work$87k - $150k
...Description Celltrion is a leading biopharmaceutical... ...’ access to advanced therapies. We have been at the forefront... ...for providing engineering support of manufacturing... ...TS/MS, manufacturing, validation, and quality assurance... .... Knowledge of cell culture, purification...Contract workTemporary workLocal areaRelocation package$146.41k - $192.16k
...advancing the next generation of cell therapy through a portfolio of... ...Biotech is seeking a Senior Engineer / Principal Engineer, Vector... ...robust, scalable processes for GMP manufacturing. The level and... ...Tangential Flow Filtration (TFF). Lead or support the translation of...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$96.27k - $126.35k
...the next generation of cell therapy through a portfolio of... ...is seeking a Senior Engineer as part of the Facilities... ..., Quality, Validation, Facilities, Supply Chain... ...lifecycle management for GMP facilities, utilities,... ...process equipment. Lead troubleshooting, root...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...1. Technical Responsibilities - Develop documentation for CQV activities - Write and execute protocols (field verification)... ...Qualifications and Experience - Bachelor’s degree in a science or engineering field (or equivalent experience) - 2–4 years’ experience in...Worldwide
- A biotechnology company in Raritan, NJ, is hiring an Operations Support Specialist for the Technical Operations team. The role involves supporting production operations in a sterile cGMP environment, collaborating with various departments, and managing inventory and data...Day shift
- ...we are advancing the next generation of cell therapy through a portfolio of innovative technologies... ...ResponsibilitiesThis individual will lead and supervise multiple units within the... ...strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless...Work at officeWorldwideShift workDay shiftAfternoon shift
- ...Job Description Job Description Role - Validation Lead Location - Raritan, NJ (Hybrid / Remote) Pay Rate - $45/hr on W2 Key Responsibilities • Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and Pharmacovigilancesystem...Local areaRemote work
- ...Job Description Job Description Position: Validation Lead Location: Raritan, NJ Remote is available; Hybrid preferred Duration: Long-Term Contract Must Have Computer System Validation (CSV) experience Validation experience with infrastructure and tools...Long term contractRemote work
$127.31k - $167.1k
...advancing the next generation of cell therapy through a portfolio of... ...Biotech is seeking a Sr. MES Engineer as part of the Manufacturing... ...Manufacturing Execution Systems Lead and will be responsible for... ...Support, Process Improvement, Validation, Supply Chain, Operations, QA...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hoursShift work$110.71k - $145.3k
...we are advancing the next generation of cell therapy through a portfolio of innovative technologies... ...a Senior Cybersecurity Architect/Engineer as part of the Information Technology... ...Model, and industry best practices. Lead enterprise-wide Zero Trust transformation...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- A leading biotechnology company in New Jersey is seeking a Facilities & Engineering Co-Op. The role involves supporting maintenance and metrology operations, managing work orders, maintaining records, and tracking equipment inventory. Candidates should be graduate students...
- Join to apply for the Facilities & Engineering Co-Op role at BioSpace Legend Biotech is a... ...Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology... ...reports. This role provides exposure to GMP compliance and facility operations....Temporary workLocal areaWorldwideFlexible hours
- ...seeking a Manager of Operations Excellence to lead and optimize CAR-T manufacturing processes at the cell therapy facility. You will shape long-term strategy, drive... ...leadership, proven experience in process engineering or manufacturing leadership, and the ability to...
$68.05k - $89.31k
...we are advancing the next generation of cell therapy through a portfolio of innovative... ...myeloma. Legend Biotech is seeking an IT Validation Analyst as part of the R&D Systems... ...Bachelor’s Degree in a Life Science, IT, Engineering or a related field ~1-3 years of hands...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$109.5k - $146k
...Description Celltrion is a leading biopharmaceutical company that... ...’ access to advanced therapies. We have been at the forefront... ...for managing Frontline Plant Engineers (4-6) to support the commercial... ...Control Engineering, Validation, TSMS, etc. Staff Development...Contract workTemporary workLocal areaRelocation packageShift work- ...Job Title R3 Technology Inc. seeks Validation Engineer for its Hillsborough, NJ office. Responsibilities include gathering requirements to develop product-level requirements and assisting with the high-level systems view of product design. Conduct multi-disciplined product...Work at officeRelocation
- ...Validation EngineerIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted...
- ...development.Summary of the RoleAs an Electrical Engineering Designer within our Distributed... ...generators, combined heat and power (CHP), fuel cells, and microgridsElectrical power... ...talented professionals who are eager to help lead and grow a team, while contributing to high...Work at officeImmediate startRemote workFlexible hours
$46.47k - $60.99k
...curing life‑threatening diseases. We are developing advanced cell therapies across a diverse array of technology platforms, including... .... Build strong partnerships with Manufacturing, Warehouse, Engineering, and Quality; work cross‑functionally to complete production...Full timeTemporary workFlexible hoursShift workWeekend workDay shiftAfternoon shift$46.47k - $60.99k
...Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across platforms including autologous and allogenic CAR T,... .... Build strong partnerships with Manufacturing, Warehouse, Engineering, and Quality, and work as part of a cross-functional team to...Flexible hoursShift workDay shiftAfternoon shift$47.86k - $62.82k
...Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including... ...requirements. Build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross‑functional team to...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hoursShift workDay shiftAfternoon shift- ...biopharmaceutical organization is seeking an experienced Computer Systems Validation Specialist to support business-application implementation... ...communication skills. Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field. PREFERRED EXPERIENCE...
- ...Our project managers are technical leads first, with a strong background in CQV strategy, development, and field... ...have managed teams of at least 6-8 engineers and consultants on defined scopes... ...provide commissioning, qualification, validation, start-up, project management and...Full timeWorldwide
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