Validation Lead

About the role

This role requires an independent Validation Lead to support Business Separation activities for large global and regional GxP Computerized systems with minimal supervision. The position focuses on M&A related Data Migration and infrastructure qualification in the data platform domain, specifically within the Pharmaceutical, biotechnology, or medical device industry.

Responsibilities

• Manage end-to-end validation lifecycle from inventory, assessments, remediations to final dispositions
• Lead Infrastructure Qualifications and Business Systems Validations
• Define and implement Risk based validation activities
• Write and execute documentation for all aspects of validation deliverables including Requirements, Compliance/Validation Plans, test protocols, Test Summary reports, Compliance/Validation Reports, and SOPs/WIs
• Review system test and user acceptance test scripts, Traceability matrix, and Design Specs
• Design, review, and approve Test Plans, systems and UAT test scripts, and Test procedures using QA Methodologies
• Lead and advise Junior and Senior resources

Qualifications

• 7-10 years of relevant experience in Computer System Validation
• Strong CSV expertise, especially within Acquisition/Divestiture/Separation contexts
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation
• Experience in reviewing system test and user acceptance test scripts
• Experience in QA Methodologies

Skills

• Computer System Validation experience
• M&A related Data Migration and infrastructure qualification in data platform domain
• Ability to independently support Business Separation activities with minimal supervision
• Strong verbal and written communication skills

Location: Raritan, NJ (Hybrid)

Recent experience with Acquisitions/Separations/Divestiture from J&J a huge plus.