Validation Lead

Job Responsibility

Must be able to work out of Raritan or New Brunswick Office at least 3 days a week.

Must be able to independently lead business separation activities for large global & regional GxP computerized systems with minimal supervision.

• Recent experience with acquisitions/separations/divestiture from J&J is a huge plus.
• Strong CSV expertise, especially within acquisition/divestiture/separation.
• Ability to manage end-to-end from inventory, assessments, remediations to final dispositions; infrastructure qualifications & business systems validations.
• 7-10 years of relevant experience; has experience of leading/advising junior and senior resources.
• Specifically in the pharmaceutical, biotechnology, or medical device industry.
• Experience in FDA and/or global regulated environment with good understanding of GxP standards and risk-based validation;
• Define and implement risk-based validation activities.
• Experience in writing and executing documentation for all aspects of the validation deliverables (e.g., requirements, compliance/validation plans, test protocols, test summary reports and compliance/validation reports, SOPs/WIs).
• Experience in reviewing system test and user acceptance test scripts, traceability matrix and design specs.
• Experience in QA methodologies, designing, reviewing and approving test plans, systems and UAT test scripts and test procedures.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide validation guidance, timely reviews, and escalations to TQ management.