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Validation Lead
Job in
Raritan, Somerset County, New Jersey, 08869, USA
Listed on 2026-08-14
Listing for:
Resource Logistics Inc.
Full Time
position Listed on 2026-08-14
Job specializations:
-
Quality Assurance - QA/QC
IT QA Tester / Automation
Job Description & How to Apply Below
Validation Lead
Location:
Raritan, NJ (Hybrid) $55/hr on w2
High-level responsibilities include:
- 5+ years of computer system validation (CSV) experience in GxP-regulated environments
- Hands-on experience in retro-validation activities and 21 CFR projects
- Knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness
- 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
- 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
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