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
- ...Biotech is seeking a Supervisor, QC Microbiology to support cell therapy manufacturing within Quality Operations in Raritan, NJ. You will... ...communication, and collaboration with QA, Manufacturing, Engineering, and Technical Operations to maintain compliance and advance...Suggested
- ...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 placementRemote workShift work
- ...Jersey, seeks a Supervisor, QC Microbiology to lead the quality control microbiology labs supporting cell therapy manufacturing. You will hire, develop, and manage... ...requires a Bachelor's degree in science or engineering, 6+ years in aseptic manufacturing or QC/QA in...Suggested
- ...Senior CQV Engineer - Commissioning, Qualification & Validation Contract: 6 months with potential for extension or conversion Location: Raritan... ...Commissioning, Qualification & Validation) to support a leading cell therapy manufacturing organization in Raritan, NJ....SuggestedContract workRelocation
$65k
...currently recruiting for QA Validation Specialist II LVV! .This position... ...antigen receptor (CAR) T-cell therapy. This innovative strategic... ...release. Verify Compliance with GMP and ISO Cleanroom Standards... ..., with a focused degree in Engineering, Science or equivalent...SuggestedTemporary workLocal areaMonday to FridayShift workDay shift$120k
...Validation Specialist Legend Biotech is a global biotechnology company dedicated to treating... ...are advancing the next generation of cell therapy through a portfolio of innovative... ...assessments, rationales, and approval for engineering and process changes to meet regulatory...Temporary workLocal areaWorldwideFlexible hours- ...opportunity found below. Are you a driven validation professional looking to make an immediate impact on a major GMP facility expansion? A leading global pharmaceutical company is... ...Partner closely with Maintenance, Engineering, Quality, and external vendors to ensure...Immediate start
$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$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...Flexible hoursNight shift- Legend Biotech, a global cell therapy leader, seeks an Operations Support Specialist in Raritan, NJ. You will join the Manufacturing &... ...record-keeping are essential. The role requires a Bachelors in engineering or related field, 0-1 years in cGMP biotech, and the ability...
$87.1k - $94.6k
.... Key Responsibilities CQV Execution & Safety - Perform... ..., Qualification, and Validation (CQV) activities with a strong... ...Bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences... ...- Essential experience in a GMP (Good Manufacturing Practice)...For contractorsWorldwide- ...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,...
$87k - $150k
...Description Celltrion is a leading biopharmaceutical... ...’ access to advanced therapies. We have been at the forefront... ...The Process Control Engineer is primarily... ..., driving appropriate GMP change control/deviation... ...installation, start-up and validation support of process...Contract workTemporary workFor contractorsLocal areaRelocation packageFlexible hoursShift workWeekend work$78.25k - $102.71k
...Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including... ...myeloma. Legend Biotech is seeking an Associate Manufacturing Engineer as part of the Manufacturing & Supply team based in...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hoursShift work- ...Senior Manager position leading cryopreservation and cell therapy manufacturing operations at a Raritan, New Jersey... ...; advanced degree or science/engineering focus preferred Minimum eight years... ...manufacturing roles Experience operating in GMP production environments...
- ...Raritan NJ. Our Raritan NJ Cell Therapy facility is scaling up operational... ...Manager is responsible for leading and driving long-term... ...focused degree in Science or Engineering is preferred Experience... ...Good Manufacturing Practices (GMP) production environment Experience...Full timeWork experience placementLocal areaImmediate start
- ...manufacturing for Johnson & Johnson's cell therapy facility in Raritan, NJ.... ...performing teams. Responsibilities Lead manufacturing operations... ...(advanced degree in Science or Engineering preferred). At least 8 years of relevant GMP manufacturing experience. Prior...
$146.41k - $192.16k
...advancing the next generation of cell therapy through a portfolio of... ...Biotech is seeking a Senior Engineer / Principal Engineer, Lentivirus... ...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$57.45k - $75.4k
.... Headquartered in Somerset, New Jersey, it develops advanced cell therapies across a diverse array of technology platforms including autologous... ...complete documentation in SOPs, logbooks, and other GMP documents. Demonstrate training progression through assigned...Flexible hoursShift workDay shift$57.45k - $75.4k
...Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including... ...Accurately complete documentation in SOP’s, logbooks and other GMP documents. Demonstrate training progression through assigned...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hoursShift workAfternoon shift$72.8k - $80.1k
.... 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- ...The Validation Engineer is responsible for executing, maintaining, and continuously improving site validation activities to ensure that equipment... ...while maintaining compliance with FDA, EMA, ICH Q8–Q10, EU GMP Annex 15, and applicable company procedures. # Provide...
$96.27k - $126.35k
...we are advancing the next generation of cell therapy through a portfolio of innovative technologies... ...This individual will lead and supervise multiple units within the... ...strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution...Permanent employmentFull timeTemporary workFor contractorsWork at officeLocal areaWorldwideFlexible hoursShift workDay shiftAfternoon shift- ...Job Details: • 7-10 years' experience in Computer System Validation ERP/WMS, R&D systems • A senior consultant with expert knowledge... ...proactively and independently. • Ability to interact and lead conversations and meeting with Business Partners independently...
- ...Validation Lead Location: Raritan, NJ Hybrid/Remote Position Type: Contract Key Responsibilities: Skills - Computer System Validation – validating Dashboard, Data Lake, Data Platform • Candidates need to have hands-on experience in validating Data Platform...Contract workRemote work
$193.63k - $254.14k
...and, one day, curing life‑threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our...Permanent employmentFull timeTemporary workFor contractorsWork experience placementWork at officeLocal areaWorldwideFlexible hoursShift work- ...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...
$87k - $150k
...continuous improvement, process validation and technology transfer. It... ...and equipment knowledge of cell culture or purification functions... ...# Thorough understanding of GMP requirements for a large-... ...S. in Biology, Biochemistry, Engineering or related science with a minimum...Temporary workImmediate startRelocation packageShift work- Job-ID32293289Reference26-00631 Job Summary: Shop Floor CSV/CSA Lead/Engineer responsible for leading and executing validation deliverables across the lifecycle in regulated manufacturing and laboratory GMP/GLP environments. The role includes automation/controls...
$50 per hour
...during procedures. Qualifications: Required: ~ Active, valid ARRT and NJ DEP license. ~ Basic Life Support (BLS) through... ...healthier communities, one person and one community at a time. As the leading academic health system in New Jersey, we advance innovative...Hourly payFull timeTemporary workPart timeWork experience placementLocal areaFlexible hoursShift workWeekend work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Cell Therapy CQV Engineer — GMP Validation Lead. Be the first to apply!





