Validation Lead

About the Role

This position involves independently supporting Business Separation activities for large global and regional GxP Computerized systems with minimal supervision. Recent experience with Acquisitions, Separations, or Divestitures—particularly from J&J—is a significant advantage.

Responsibilities

• Manage end-to-end processes for system inventory, assessments, remediations, and final dispositions.
• Oversee Infrastructure Qualifications and Business Systems Validations.
• Define and implement risk-based validation activities in an FDA and/or globally regulated environment.
• Write and execute documentation for all validation deliverables, including Requirements, Compliance/Validation Plans, test protocols, Test Summary Reports, Compliance/Validation Reports, SOPs, and Work Instructions (WIs).
• Review system test scripts, user acceptance test (UAT) scripts, Traceability Matrices, and Design Specifications.
• Apply QA methodologies to design, review, and approve Test Plans, system and UAT test scripts, and Test Procedures.

Requirements

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