Senior Validation Lead - CSV & Annex 11 Remediation
Raas Infotek
Raas Infotek is seeking a Validation Lead - CSV with Annex 11 Remediation in Raritan, NJ. Hybrid work model available. The role requires extensive experience in computer system validation (CSV) in GxP environments, including retro-validation and remediation projects. Responsibilities include writing and executing validation deliverables, reviewing test scripts and traceability matrices, leading QA practices, and coordinating with remote teams to deliver timely compliance across multiple projects. #J-18808-Ljbffr Raas Infotek
- Legend Biotech is seeking a Sr. CSV/CQV Specialist for the... ...commissioning, qualification and validation support to all computerized... ..., vendor coordination and remediation efforts. The ideal candidate... ...deep knowledge of 21 CFR Part 11, EU Annex 11, and ICH guidelines, plus...Senior
- ...Clinical Computer System Validation (CSV) Manager, located in... ...membersThis role will lead globally diverse teams... ...collaboration skills at the senior leadership level, and... ...including 21 CFR Part 11, Part 210, Part 211 and... ...Global Regulations like EU Annex 11, SOX, HCC, Security...SuggestedFull timeLocal areaImmediate start
- Job Role: Validation Lead -CSV with Annex 11 Remediation Location: Raritan, NJ (Hybrid) Visa: USC/GC/H1B Job Description: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands‑on experience in retro-validation activities and...SuggestedH1bRemote work
- ...Description We are seeking a Senior Validation Engineer with solid hands-on validation... ...activities Knowledge of CSV methodology and required... ...GMPs (21 CFR Part 820), EU GMPs (Annex 1) requirements Knowledge... ...standards, 21 CFR Part 11) Excellent technical writing...SeniorContract workFor contractorsFlexible hours
$110.71k - $145.3k
...Legend Biotech is seeking a Sr. CSV/CQV Specialist as part of... ..., Qualification and Validation support to all computerized... ...deviations, corrections and remediation efforts of computerized systems... ...for 21 CFR Parts 210, 211, 11, EU Annex 11 among others. Works with...SeniorTemporary workFor contractorsWork experience placementWork at officeLocal areaWorldwideFlexible 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...
- Legend Biotech USA in Raritan, NJ seeks a Sr. CSV Specialist to support Commissioning, Qualification and Validation of computerized systems in a cGMP cell therapy manufacturing plant. This role requires independence, strong CSV expertise, and collaboration across cross-...Senior
- ClinDCast LLC is seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI in a GxP-regulated environment. The ideal candidate will validate enterprise applications while ensuring FDA and global regulatory standards...SeniorRemote jobWork from homeFlexible hours
- ...Description Position Description: Our project managers are technical leads first, with a strong background in CQV strategy, development,... ...800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services...SeniorFull timeWorldwide
- 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...
- ...works closely with computerized system validation, Information Technology, business system... ...Opportunity to work across Quality, CSV, IT, business, and vendor teams. Hands... ...regulatory compliance. Apply 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5, and risk-based...SeniorFull time2 days per week1 day per week
$127.31k - $167.1k
...GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines... ...adhere to Legend CSV and SDLC procedures,... ...enhancement and validation activities inclusive... ...communicated, tracked, and remediated, in compliance with... ..., Legend Functional Leads, Legend Project Management...SeniorPermanent employmentFull timeTemporary workFor contractorsWork experience placementLocal areaWorldwideFlexible hours$53 - $63 per hour
...Entra ID — supporting implementation, validation, and ongoing lifecycle management. ·... ...oversight. · Partners with IT, business, CSV and vendor teams to apply risk-based... ...compliance with 21 CFR Part 11 and Eudralex Volume 4 Annex 11 as applied to electronic records,...Senior- ...Consulting - Computer System Validation- Life SciencesWe are... ...for candidates at Senior Consultants levels who are... ...Computerized System Validation (CSV) within Life Sciences... ...like 21 CFR Part 11, GxP and GAMP 5.• Experience... ...are industry experts that lead complex change agendas...SeniorFull timeTemporary workWork experience placement
- ...Description We are seeking an innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to the growth... ..., including but not limited to facility plans, validation, CSV and other technical protocols and reports, trend reports,...SeniorFlexible hours
- ...candidate for a role 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...Remote work
$137k - $235.75k
...Medicines is looking for outstanding scientists and leaders whose responsibilities include:Be a hands-on scientific and technical leader, leading a portfolio of RWE projects, developing best practices, and mentoring team members.Identify common technical requirements for RWE...SeniorFull timeLocal areaImmediate start- Johnson & Johnson in United States, New Jersey (Raritan) seeks a Senior Director, US CAR-T Operations Lead to drive manufacturing operations and strategic alignment across the Advanced Therapies ecosystem. The role partners with Legend Biotech, shaping long-term capabilities...Senior
- Johnson & Johnson seeks a Senior Director, US CAR-T Operations Lead to drive CAR-T manufacturing across clinical and commercial supply in partnership with Legend Biotech, based in New Jersey. The role leads strategic operations, quality, and supplychain initiatives across...Senior
$210k - $256.67k
...rollout projectsHave experience in gathering, validating, synthesizing, documenting, and... ...interpersonal and influencing skills, especially at senior client levels.Committed to advancing the... ...consultants are industry experts that lead complex change agendas driven by...SeniorFull timeTemporary workWork experience placementRemote work$109k - $174.8k
...best talent for Clinical Project Manager, Senior Analyst.The Clinical Project Manager is... ...with the team to assess and remediate impact to scope, budget, timelinesProvide... ...productivity and cohesivenessExperience leading without authority and in multi-functional...SeniorFull timeLocal areaImmediate start- ...of AmericaJob Description:Johnson & Johnson is recruiting for a Senior Manager, External Manufacturing MSM Operations. This position... ...member of the Surgical Vision Supply Chain team, responsible for leading productivity initiatives, materials management, and supply...SeniorFull timeContract workLocal areaImmediate start
- First Onsite is seeking a Branch Manager II to lead a high-performing team and oversee all branch operations. You will drive project execution, profitability, and client satisfaction while mentoring other managers and collaborating with sales and regional leadership. You...Senior
- Specified Technologies is seeking a Senior Operations Manager to lead end-to-end operations, focusing on SIOP, planning, procurement, and logistics. This hybrid role is based in Somerville, New Jersey, where the candidate will ensure alignment between demand, supply, and...Senior
- Nestlé Health Science is recruiting for a Senior Specialist of Regulatory Operations & Compliance (ROC) in the US. You will guide above-brand regulatory activities, support cross-functional teams, and ensure compliance for NHSc products in the US. The role requires a strong...Senior
$145.5k - $242.5k
...Operational Excellence & IT Compliance Lead Job Description Position... ...principles, 21 CFR Part 11 expectations, and applicable... ...and compliance partner for validation strategy, lifecycle controls,... ...Management, Audit Readiness & Remediation Lead or approve system risk...Temporary workWork experience placementRelocation packageFlexible hoursShift work- Brother International Corporation in New Jersey is seeking a Senior Manager, Product & Business Operations to lead a team driving strategic integration of product planning with forecasting, demand, and financial outcomes. You will partner with Sales, GTM, Finance, and Supply...SeniorRemote work2 days per week
$137k - $236.33k
...BrazilJob Description:We are searching for the best talent for a Senior Principal, Cyber Experience & AI Engagement professional to be... ...product management, employee experience, and omnichannel engagement.Lead the strategy and evolution of AI-powered cybersecurity...SeniorFull timeTemporary workLocal areaImmediate start$85k
...an effort to drive sales growth, profitability and investments. Lead Product Finance support for the various assigned Categories. Gross... ...Information$85K plus bonusSummaryType: Full-timeFunction: Accounting/AuditingExperience level: Mid-Senior LevelIndustry: Consumer GoodsSenior$147.3k - $243k
...analyses and presenting statistical results. Lead complex programs such as NDA/BLA/MAA... ...assigned Qualifications Minimum Required: Senior Principal Biostatistician level: Master's... ...guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines Experience with SAS...SeniorFlexible hours
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