Validation Lead at Raritan, NJ(Hybrid)

Location: Raritan, NJ (Hybrid)

About the Role

Must be able to independently support Business Separation activities for large global and regional GxP Computerized systems with minimal supervision. Recent experience with Acquisitions/Separations/Divestiture from J&J is a huge plus.

Responsibilities

• Manage end-to-end validation processes from inventory, assessments, and remediations to final dispositions.
• Oversee Infrastructure Qualifications and Business Systems Validations.
• Define and implement risk-based validation activities.
• Write and execute documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, test protocols, Test Summary Reports, Compliance/Validation Reports, SOPs/WIs).
• Review system test scripts, user acceptance test scripts, Traceability Matrix, and Design Specs.
• Apply QA methodologies, design, review, and approve Test Plans, systems, UAT test scripts, and Test procedures.

Requirements

• 7–10 years of relevant experience in Computer System Validation (CSV), particularly within Acquisition/Divestiture/Separation.
• Experience leading and advising junior and senior resources.
• Experience in the pharmaceutical, biotechnology, or medical device industry.
• Experience in an FDA and/or globally regulated environment with a strong understanding of GxP standards and risk-based validation.
• Strong verbal and written communication skills.