Validation Lead

Position: Validation Lead

Location: Raritan NJ***HYBRID***

Duration: 1 Year

Job Responsibility:
Must be able to work out of Raritan or New Brunswick Office atleast 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 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.
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