Validation Lead

About the Role

This is a 1-year hybrid position based in Raritan, NJ, focused on supporting Business Separation activities for large global and regional GxP Computerized systems with minimal supervision. The role involves managing end-to-end validation processes, including inventory, assessments, remediations, and final dispositions, as well as infrastructure qualifications and business systems validations.

Responsibilities

• Independently lead and support Business Separation activities for GxP Computerized systems.
• Manage validation processes from inventory to final dispositions, including infrastructure qualifications and business systems validations.
• Define and implement risk-based validation activities in compliance with GxP standards.
• Write, execute, and review validation documentation, including requirements, compliance/validation plans, test protocols, test summary reports, compliance/validation reports, SOPs, and work instructions.
• Review system test scripts, user acceptance test scripts, traceability matrices, and design specifications.
• Apply QA methodologies to design, review, and approve test plans, systems, UAT test scripts, and test procedures.
• Lead and advise junior and senior resources.

Requirements

• 7-10 years of relevant experience in computer system validation, specifically in the pharmaceutical, biotechnology, or medical device industry.
• Strong expertise in CSV, particularly within acquisition, divestiture, or separation contexts.
• Experience with M&A-related data migration and infrastructure qualification in data platform domains.
• Recent experience with acquisitions, separations, or divestitures (experience from J&J is a plus).
• Experience in FDA and/or globally regulated environments with a solid understanding of GxP standards and risk-based validation.
• Strong verbal and written communication skills.