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Contract role: Pharma Validation Lead at Raritan, NJ (Onsite Hybrid Model)

Hybrid • Posted 1 day ago • Updated 1 day ago

Contract Corp To Corp

Contract W2

Contract Independent

75% Travel Required

Hybrid

Fitment

Dice Job Match Score™

⭐ Evaluating experience...

Job Details

Skills

test planning
GxP
system testing
Communication Skills
Quality Management
Team management
biotechnology
Team Working
Acceptance Testing
Medical Materials
Risk-Based Testing
Traceability Matrix
Validation Protocols
FDA Regulations
Title 21 of the Code of Federal Regulations

Summary

Validation Lead
Raritan, NJ (Onsite Hybrid Model)

Long Term Contract

Job Details:

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 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 (etc. 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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10421780
Position Id: 2026-64243
Posted 1 day ago

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