Validation Lead- CSV Annex Remediation
Listed on 2026-09-01
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IT/Tech
IT QA Tester / Automation, IT Consultant
Validation Lead- CSV with Annex 11 Remediation
Duration:
Long Term Contract
Location:
Raritan, NJ (Hybrid) Rate: $70/hr.
Interview mode:
Video Conference/In-Person Joining: ASAP This is the description.
5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on validation and deployment of SAP ERP, WMS, and enterprise supply chain applications; strong knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.
Demonstrated delivery experience with Generative AI and Agentic AI solutions, including validation/governance of AI-enabled systems, LLM-based applications, AI agents, orchestration frameworks, prompt/model lifecycle controls, and risk-based compliance approaches in regulated environments.
Experience in the Pharmaceutical, biotechnology, or medical device industry
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports)
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.
Strong verbal and written communication skills.
Ability to work as a team player, lead a team or accomplish tasks without supervision.
Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
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