Validation Lead

Key Responsibilities

• Validate and implement infrastructure systems and tools (e.g., AWS, Azure, JIRA, ServiceNow)
• Manage multiple dispositions for multiple J&J Managers with limited supervision
• Lead end-to-end validation processes from inventory, assessments, remediations to final dispositions
• Define and implement risk-based validation activities
• Write and execute documentation for all validation deliverables (Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports, SOPs/WIs)
• Review system test and user acceptance test scripts, Traceability Matrix, and Design Specifications
• Design, review, and approve Test Plans, systems, UAT test scripts, and Test Procedures using QA Methodologies
• Provide validation guidance, timely reviews, and escalations to TQ management
• Work with remote teams and support multiple changes/projects simultaneously

Required Experience

• 7-10 years of relevant experience, specifically in the pharmaceutical, biotechnology, or medical device industry
• Hands-on experience with divestiture/separation, including Manufacturing site cutovers (infrastructure and applications)
• Proven track record with large acquisitions and separations
• Strong CSV expertise, especially within Acquisition/Divestiture/Separation contexts
• Experience in FDA and/or global regulated environments with strong understanding of GxP standards and risk-based validation
• Experience leading and advising both junior and senior resources

Skills

• Strong verbal and written communication skills
• Ability to work as a team player, lead a team, or accomplish tasks without supervision
• Recent experience with J&J divestiture/separation is a huge plus