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
- ...support Business Separation activities for large global and regional GxP Computerized systems. Candidates should have over 10 years of... ...biotechnology, or medical device industries, with specific experience in FDA-regulated environments. The role requires strong leadership...SuggestedRemote work
- ...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
$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...SuggestedWork at officeFlexible hours- ...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
- 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...Suggested
- 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...
$120k
...advance the promise of an immunotherapy in the treatment of multiple myeloma. COMPANY: Legend Biotech USA, Inc JOB TITLE: Validation Specialist JOB DUTIES: Execute site validation activities to the current regulatory and site requirements and address deviations associated...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours$81.04k
...Biotech USA, Inc. seeks a Risk Assessment Specialist in Raritan, NJ to: conduct Quality Risk... ...equipment; develop, execute, and review validation master plans, cleaning validation, and... ...expertise on ICH Q9 Quality Risk Management, FDA, and cGMP compliance; perform related...Temporary workLocal areaWorldwideFlexible hours$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...- ...IT Quality Compliance Specialist/Analyst Hybrid role--Local Candidates... ...assurance mindset for computer system validation for GMP, GDP, GLP space.... ...to read and interpret global GXP regulations, as well as data integrity... ..., Food & Drug Administration (FDA), and other regulatory...Local area
- ...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...
- ...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...
- ...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 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
- ...biotechnology manufacturing expansion project in Raritan, NJ. The role will involve supporting commissioning, qualification, and validation for aseptic processing isolators and GMP manufacturing equipment. The ideal candidate should have a Bachelor’s degree in Engineering...
- CQV Engineer - Biotech Manufacturing, Isolators & VHP 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...
$80k - $90k
Merck & Co. is looking for a Process Engineer to plan and execute validation assignments in Piscataway Township, New Jersey. This role involves preparing validation protocols, managing post-approval projects, and ensuring compliance with established quality standards....- ...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...
- 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...
- 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
$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- ...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
- ...Process Automation Engineer Design, install, and validate SQL file pull for the audit trail into a configurable format. Install McAfee... ...Configuration. Install Acronis Backup onto four servers and configure a GXP server for those backups. Develop archive strategy for process...
$84.5k - $162k
...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...Full timeContract workTemporary workLocal areaMonday to FridayNight shiftWeekend work- ...gauging systems. Develop and utilize digital technologies for manufacturing component designs, performing CNC machine simulations to validate layouts, functional performance, and production output rates. Create and modify CNC programs to manufacture products to drawing...Remote workFlexible hours
- ...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
- A technology solutions company in Raritan is seeking a Mobile Application Developer responsible for ensuring the quality and performance of applications. This role involves understanding code workflows, creating test cases, and collaborating with technical teams to improve...
- Gilder Search Group is seeking an Operations Readiness Project Engineer in Raritan, NJ. This onsite role supports multiple biologics and cell therapy projects through commissioning and operational startup. The ideal candidate will have 3–7 years of relevant experience ...
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