W2 | CSV Validation Lead in Raritan, NJ; Hybrid

Job Title - CSV Consultant

Location:

Raritan, NJ (Hybrid)

Role Overview:
Must be able to support Business Separation activities for large global & regional GxP Computerized systems. Must work three days a week from the office in Raritan.

• Support Business Separation activities; manage end-to-end from inventory assessments and remediations to final dispositions.
• Work 3 days a week from office in Raritan.
• Provide validation guidance, timely reviews, and escalations to TQ management.
• Provide support to remote teams and manage several changes/projects simultaneously.
• Be a team player, lead a team or accomplish tasks without supervision.
• 10+ years of relevant experience, leading and advising junior and senior resources.
• Experience with SAP and ERP and acquisitions/separations/divestitures, especially from J&J.
• Experience in the pharmaceutical, biotechnology, or medical device industry.
• Experience in FDA and/or global regulated environments, with good understanding of GxP standards and risk-based validation.
• Define and implement risk-based validation activities.
• Write and execute documentation for validation deliverables including requirements, compliance/validation plans, test protocols, test summary reports, compliance/validation reports, SOPs/WIs.
• Review system test and UAT test scripts, traceability matrix, design specs.
• Experience in QA methodologies, designing, reviewing, and approving test plans, system and UAT test scripts, and test procedures.
• Strong verbal and written communication skills.