Lead CSV Consultant

Location: Raritan, NJ (Hybrid)

Duration: 1 year

About the Role

We are seeking a Lead CSV Consultant with strong expertise in Computer System Validation (CSV), particularly within Supply Chain Management and SAP systems. Recent experience with Acquisitions, Separations, or Divestitures from Johnson & Johnson is a significant plus. The ideal candidate will have a proven track record in managing end-to-end validation processes, from inventory assessments and remediations to final dispositions.

Responsibilities

• Lead and advise junior and senior resources in CSV activities, specifically in the pharmaceutical, biotechnology, or medical device industry.
• Define and implement risk-based validation activities in an FDA and/or globally regulated environment with a strong understanding of GxP standards.
• Write and execute documentation for all aspects of validation deliverables, including requirements, compliance/validation plans, test protocols, test summary reports, compliance/validation reports, SOPs, and work instructions.
• Review system test scripts, user acceptance test (UAT) scripts, traceability matrices, and design specifications.
• Apply QA methodologies to design, review, and approve test plans, systems, UAT test scripts, and test procedures.
• Provide validation guidance, timely reviews, and escalations to Technical Quality (TQ) management.
• Work collaboratively with remote teams and manage multiple changes or projects simultaneously.

Requirements

• 7–10 years of relevant experience in CSV, with a focus on acquisitions, separations, or divestitures.
• Experience in the pharmaceutical, biotechnology, or medical device industry.
• Strong understanding of FDA and/or global GxP regulations and risk-based validation.
• Proven ability to lead teams, work independently, and manage tasks without supervision.
• Excellent verbal and written communication skills.