Contract role: Validation Lead at Raritan, NJ (Onsite – Hybrid Model)|| W2 Only
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2026-08-11
Listing for:
Yochana
Full Time, Contract
position Listed on 2026-08-11
Job specializations:
-
Quality Assurance - QA/QC
IT QA Tester / Automation, QA Specialist - Analyst/Manager, Quality Engineering
Job Description & How to Apply Below
- :5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness
- .Experience in the Pharmaceutical, biotechnology, or medical device industr
- yExperience 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 (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Report
- sExperience 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 managemen
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