CSV Validation Specialist (FDA/GxP)
Katalyst CRO
Katalyst CRO is looking for a CSV Consultant in Raritan, NJ to support system validation activities in a regulated environment. The consultant will ensure compliance with FDA guidelines, contribute to validation documentation, and work within the System Development Lifecycle (SDLC). Candidates should have extensive experience in pharmaceutical or biotechnology industries, with a strong background in Computer System Validation (CSV) and knowledge of GxP standards. Excellent communication skills and ability to handle multiple projects are essential. #J-18808-Ljbffr Katalyst CRO
$127.31k - $167.1k
...myeloma. Legend Biotech is seeking a Sr. QA Validation Specialist, CSV & Equipment as part of the Quality team... .... Knowledge of cGMP regulations and FDA/EU guidance related to GMP... ...products is a plus. Strong knowledge of GxP compliance. Experience in cGMP regulatory...SuggestedPermanent employmentFull timeTemporary workFor contractorsWork experience placementWork at officeLocal areaWorldwideFlexible hours- ...Job Title: CSV Consultant - 10+ Years of Exp is Mandatory to have... ...for large global and regional GxP computerized systems within a... ...of relevant Computer System Validation (CSV) experience. ~ Experience... .... ~ Experience working in FDA and/or globally regulated GxP...SuggestedContract workRemote work
- ...are seeking an innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to the growth of the... ...IDMO, including but not limited to facility plans, validation, CSV and other technical protocols and reports, trend reports, risk...SuggestedFlexible hours
- ...Technologies LLC is seeking a Quality/Validation Engineer with hands‑on expertise in GxP‑regulated environments and Computer System Validation (CSV). This role involves full lifecycle validation... ...with 21 CFR Part 11, GAMP 5, FDA, and QMS standards. Apply risk‑based validation...SuggestedFull time
- Legend Biotech is looking for a Sr. QA Validation Specialist, CSV & Equipment in Raritan, NJ. This role involves overseeing validation and qualification activities for systems and processes in a GMP cell therapy manufacturing plant. Ideal candidates have at least 7 years...Suggested
$93.46k - $122.67k
Job Overview QA Validation Specialist III role at BioSpace, based in Raritan, NJ. Exempt level position... .... Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing... ...products is a plus. Strong knowledge of GxP compliance. Experience with cGMP regulatory...Work at officeFlexible hours- Experienced Validation lead to support end to end validation ownership... ...management or Business Analysis in GxP application area Act as single... ...support regarding SDLC and CSV processes, ensuring best... ...) regulatory requirements and FDA 21 CFR Part 11 Clear written and...
- A leading technology consulting firm is looking for an Experienced Validation Lead to support the end-to-end validation of a Unified Regulatory Platform built on Veeva and AWS cloud technology. The ideal candidate will have over 8 years of experience in Computer System...
- ...Job Description Job Description We are seeking a Senior Validation Engineer with solid hands-on validation experience and a collaborative... ...Review (PR) and requalification activities Knowledge of CSV methodology and required lifecycle document content including risk...Contract workFor contractorsFlexible hours
- ...reviews and coordinate with stakeholders. Execute SOP-driven validations, produce IQ/OQ/PQ deliverables, and ensure ALCOA+ data... ...GMP upkeep. Education and Experience: Minimum 8 years in GxP/analytical lab settings with hands-on validation of GMP instruments...Remote work
- ...documentation for all aspects of the computer system validation life cycle. Design, deliver, support and maintain GxP computerized systems and security of the... ...acceptable. Required Skills CAPA CGXP GAMP HP ALM CSV 21 CFR Audit Trial Agile GAP Analysis Service...
- Legend Biotech is seeking a Sr. QA Validation Specialist in Raritan, NJ, to provide quality oversight for validation and qualification activities in a cell therapy manufacturing setting. Ideal candidates must possess a Bachelor's Degree in Science and have over 7 years...
$81.04k
Legend Biotech USA, Inc. is seeking a Risk Assessment Specialist based in Raritan, NJ. The ideal candidate will conduct Quality Risk Assessments and collaborate with teams across QA, QC, Manufacturing, Engineering, and R&D. This position requires a BS degree and experience...- Legend Biotech USA is seeking a Risk Assessment Specialist in Raritan, NJ, responsible for conducting Quality Risk Assessments (QRM) and... ...with QA, QC, and Engineering teams to enhance compliance with FDA and GMP standards. The ideal candidate holds a BS degree in a relevant...Full time
- ...obsessed with how it will be done. Key Responsibilities CQV Execution & Safety - Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety - Deliver C&Q activities in alignment with project schedules - Track and...For contractorsWorldwide
- Job Description Job Description Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments...Worldwide
- ...seasoned professional with over 8 years of experience in Computer System Validation and Quality Management in GxP applications. This role involves guiding project teams through the SDLC, applying FDA guidance, and interacting with various stakeholders to interpret...
- A leading technology organization in Raritan, New Jersey, seeks a skilled professional to document software and validate specifications for lab instrumentation. Key tasks include gathering requirements, creating infrastructure and data flow diagrams, and performing risk...
- ...This has helped us expand into new sectors and steadily grow. Job Description Responsibilities: Investigates and troubleshoots validation problems for equipment and/or performance processes and conducts equipment qualification activities. Conducts analyses of testing...
- A leading technology solutions provider in New Jersey is seeking a Testing Specialist with experience in the Lifesciences industry. The role involves managing testing processes, ensuring adherence to Agile methodologies, and collaborating with various stakeholders. Ideal...
- ...Job Description Job Description Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory...
- ...designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives...Contract workTemporary workLocal areaMonday to FridayNight shiftWeekend work
- Legend Biotech is seeking a Manufacturing Engineer, Technical Support in Raritan, NJ. This role involves supporting CAR-T manufacturing processes and acting as a subject matter expert. The candidate should have a Bachelor's degree in engineering, with 3-5 years of operations...
$83.71k - $109.87k
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and...Permanent employmentFull timeTemporary workFor contractorsWork at officeLocal areaWorldwideFlexible hours$76k - $96.5k
Job Description Job Description Manufacturing Engineer - Job Description This hands-on Manufacturing Engineer role supports sustaining engineering and production of complex, custom semiconductor capital equipment in a low-volume, high-complexity, engineer-to-order...Permanent employmentShift work- Job Description Job Description Location: New Jersey Employment Type: Full Time Department: Engineering Reports To: Vice President of Operations About Us SICAM has been accelerating customers' product development since 1990 with proven rapid prototyping...Full time
- ...Modem System Validation Engineer Bedminster, NJ (Hybrid) 12 Months Looking for someone with strong 5G protocol and troubleshooting skills. Responsibilities: Conduct research and analysis to define features and functions for 5G advanced and 6G. A firm...
- ...who thrives in a fast-paced environment and is passionate about learning and problem-solving. This role is responsible for the validation of production powertrain control modules, including hardware, software, and calibrations—primarily in the battery electric vehicle...Full timeImmediate start
- Amneal is looking for a Process Engineer to plan and execute process and cleaning validation assignments in Piscataway Township, New Jersey. The role requires a sound understanding of pharmaceutical engineering principles and the ability to manage multiple projects effectively...
- Legend Biotech is seeking a Junior Associate Facility Engineer to join the Facilities & Engineering team in Raritan, NJ. This role supports the operation and maintenance of equipment in a Cell Therapy manufacturing facility, working on collaborative teams to ensure efficiency...
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