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
- ...expertise in Computer System Validation ERP/WMS, R&D systems • 7-10... ...consultant with expert knowledge of GxP and Computer System Validation... ...authoring and reviewing all CSV validation deliverables. •... ...GxP systems Application of FDA guidance’s and industry standards...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- ...Validation Specialist, Computerized SystemsThe Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments,...SuggestedWork experience placement
- 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
- 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...
- Insight Global is seeking an Associate Engineer for a leading pharmaceutical manufacturer to support Commissioning & Qualification (C&Q) activities for CTUs and GMP equipment. You will execute IQ, OQ, and PQ protocols and maintain GMP documentation. Requirements include...
- - Validation Lead(Computer System Validation - GenAI, Agentic QMS) Location - Raritan, NJ(Hybrid) $... ...experience in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. •...Remote 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...Flexible hours
- ...Job TitleR3 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
$72.8k - $80.1k
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, we provide accelerated operational...Worldwide- ...Validation Engineer IIICreating a Healthier World through Accessible Biologics:Kashiv BioSciences... ...as the validation representative during FDA, customer, and internal audits.Provide... ...specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change...Full timeContract workLocal areaFlexible hours
- ...Computer Systems Validation SpecialistDefine validation strategy for computerized systems and platforms utilized in GxP space.Create validation deliverables such as validation plan, test protocols, traceability matrix and execution of protocolsParticipate in user review...Remote work
- ...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...
$87.1k - $94.6k
...done. We're obsessed with how it will be done.Key ResponsibilitiesCQV 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 report...For contractorsWorldwide- ...Piper Companies is currently looking for an experienced ( CQV) Validation Engineer in Raritan, NJ to work for an innovative and growing... ...and guidelines related to equipment validation (e.g., FDA, EU, ICH). Experience with IQ/OQ/PQ protocols, process validation...
- Piper Companies is seeking a Validation Engineer (CQV) in Raritan, NJ to support a leading cell therapy organization. This role focuses on commissioning, qualification, and validation of laboratory equipment within a GMP-regulated cell therapy environment. Responsibilities...Long term contract
$40 - $45 per hour
Piper Companies is seeking a Validation Engineer (CQV) in Raritan, NJ to support a leading cell therapy organization . This role focuses... ...Ensure equipment qualification and data integrity meet GMP and FDA standards. Support equipment installation, lifecycle management...Long term contract- ...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
$91.7k - $135k
Engineer III, Manufacturing EngineeringThe Engineer III, Manufacturing Engineering, at Thermo Fisher Scientific will play a crucial role in enhancing production processes and systems within the LCD (Lab Chemical Division). This role will collaborate with equipment engineering...Temporary workWork at office- Manufacturing EngineerFloor Oriented5-7 years of manufacturing / process engineering experienceAbility to read printsProven record of continuous improvementFiberglass experience is a plusAutomotive / Agricultural experience is preferredFloor communication skill is a must...
$104.8k - $192.2k
Location: Anywhere in Country At EY, we’re all in to shape your future with confidence. We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world...For contractorsSummer holidayFlexible hours$75k - $142.5k
...of the project.ResponsibilitiesDevelop, execute and implement validation documentation - specification documents, SOPs, IQ/OQ/PQ equipment... ....A basic understanding of government regulations such as FDA cGMPs.PreferredBachelor's degree in engineering, science or computer...Temporary workWork at officeLocal areaImmediate startRemote workMonday to Friday- ...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
- Johnson & Johnson is seeking an Automated Labeling Specialist at our Raritan distribution campus. You will... ...products, and ensure compliance with FDA labeling requirements. In this role you will participate in validation activities for labeling equipment changes, work...
$150k - $250k
...analysis to optimize circuit performance and reliability.Prototype and test power converters, specifically DC-DC power converters, to validate design specifications.Document design processes, test results, and project milestones to ensure compliance and facilitate...- ...and validationTraining of manufacturing technicians on new product releases and on changes to existing processesQualification and validation of new processes/products and of changes made in manufacturing (materials, processes, test equipment, etc.) Statistical analysis...Temporary workWorldwideFlexible hours
- ...function and assuring no quality escapes Document the complete test process Training technicians on assembly and test process. Validate technicians on competency to assembly & test process Requirements: 2-5 years experience in a manufacturing...
$76k - $96.5k
Manufacturing EngineerThis role supports sustaining engineering and production of highly complex semiconductor capital equipment in a low-volume, high-complexity, engineer-to-order environment. The Manufacturing Engineer works hands-on on the manufacturing floor as the...Permanent employmentRelocationShift work- ...installation, scale-up, optimization, automation, trouble shooting and validation of manufacturing processes or equipment. Aids in the... ...knowledge of pharmaceutical/medical device/diagnostics cGMPs and FDA compliance is strongly preferred. ~ Experience with design...Work at office
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