Validation Lead

Position

Validation Lead

Raritan, NJ – Hybrid (work out of Raritan or New Brunswick Office at least 3 days a week)

1 year

• Lead business separation activities for large global and regional GxP computerized systems with minimal supervision.
• Independently manage end‑to‑end separation, including inventory, assessments, remediations, and final dispositions.
• Oversee infrastructure qualifications and business systems validations.
• Develop risk‑based validation plans and execute documentation such as validation plans, test protocols, test summary reports, compliance/validation reports, SOPs, and work instructions.
• Review system test and user acceptance test scripts, traceability matrices, and design specifications.
• Design, review, and approve test plans, system UAT test scripts, and test procedures.
• Provide validation guidance, timely reviews, and escalations to TQ management.
• Collaborate with remote teams and support multiple change initiatives simultaneously.
• Lead and mentor junior and senior resources.

• 7–10 years of relevant experience in the pharmaceutical, biotechnology, or medical device industry.
• Experience with FDA and/or global regulated environments and a strong understanding of GxP standards and risk‑based validation.
• Recent experience with acquisitions, separations, or divestitures, especially from Johnson & Johnson.
• Strong CSV expertise and experience in acquisition/divestiture/separation.
• Excellent verbal and written communication skills.
• Ability to work as a team player, lead a team, or accomplish tasks independently.