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
- ...focused on Technology Quality Manufacturing and MES Services. This position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-10 years of relevant experience. Key responsibilities include...SuggestedRemote work
- ...Services, LLC is seeking a qualified candidate for a role focusing on validation in the pharmaceutical industry. Candidates should have over 3... ...in Computer System Validation and a strong background in FDA regulations. The position requires strong communication skills,...Suggested
- ...industry player is seeking an IT Quality Compliance Specialist/Analyst to ensure regulatory compliance across the... ...lifecycle. This hybrid role involves managing the GxP IT Quality Assurance program, reviewing validation deliverables, and supporting inspections. Ideal candidates...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...SuggestedWork 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...Suggested
$120k
...Validation Specialist 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...Local areaWorldwide- 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...
- ...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
- 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...
- ...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...
- ...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...Flexible hours
- ...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...
- ...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
- 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
- ...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...
- Piper Companies is seeking an experienced CQV Validation Engineer in Raritan, NJ, to assist with the IQ/OQ/PQ of new instruments/equipment... ...in pharmaceutical validation environments. Strong knowledge of FDA regulations and excellent problem-solving skills are essential....
- Piper Companies is currently looking for an experienced CQV Validation Engineer in Raritan, NJ to work for an innovative and growing pharmaceutical... ...and guidelines related to equipment validation (e.g., FDA, EU, ICH). Experience with IQ/OQ/PQ protocols, process...
- ...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...
- ...applications. We are looking for a skilled UVM SystemVerilog Verification Engineer to join our dynamic team and contribute to the validation and testing of our cutting-edge communication technologies. Job Description As a UVM Verification Engineer, you will...Remote work
- ...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
- ...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...
- 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
- ...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
$80k - $90k
...seeking a Process Engineer to report to the Manager of Technical Services. The ideal candidate will execute and manage cleaning validation and post-approval projects, working collaboratively with various departments. The role requires a Bachelor's degree in Pharmaceutical...$80k - $90k
Description Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team...Flexible hours- 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...
- Insight Global is seeking an experienced Equipment Systems Integration/Configuration Engineer with strong automation/controls awareness and biotech manufacturing experience for one of our biotech clients to support CART production in central, NJ. This role will ensure ...
$76k - $96.5k
Job Description Job Description Job Title: Manufacturing Engineer Job Description This Manufacturing Engineer role focuses on sustaining engineering and supporting the production of complex, high-value semiconductor capital equipment in a low-volume, high-complexity...Permanent employmentRelocationShift work$93k - $120k
...ready for smooth transition into sustained production. You engage early in the design cycle, influence how products are built and validated, and see your work come to life on the manufacturing floor and in customer environments. Responsibilities Support NPI programs...Permanent employmentFlexible hours
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