Validation Lead

Role: Validation Lead

Location: Raritan, NJ(Hybrid)

Duration: 6+ Months

Must Have - Computer System Validation Experience M&A related Data Migration and related infrastructure qualification in data Platform domain

Job Description:

• Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems. with minimal supervision.
• Recent experience with Acquisitions/Separations/Divestiture from J&J a huge plus.
• Strong CSV Expertise, especially within Acquisition/Divestiture/ Separation. Ability to manage end-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 (etc. 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.