Validation Lead

We are looking for Validation Lead - Hybrid for our client in Raritan, NJ . Job Title: Validation Lead Job Location: Raritan, NJ Job Type: Contract Job Overview: Pay Range: $50.00hr - $55.00hr Requirement/Must Have: 7-10 years of relevant experience in Infrastructure Qualifications and Business Systems Validations. Experience leading or advising junior and senior resources. Specific experience in the pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation. Strong Computer System Validation (CSV) expertise, especially within acquisition, divestiture, and separation contexts. Experience in writing and executing documentation for all aspects of validation deliverables including requirements, compliance/validation plans, test protocols, test summary reports, and SOPs/WIs. Experience in reviewing system test and user acceptance test scripts, traceability matrices, and design specifications. Experience in QA methodologies, including designing, reviewing, and approving test plans and procedures. Strong verbal and written communication skills.

Responsibilities: Independently support business separation activities for large global and regional GxP computerized systems with minimal supervision. Manage end-to-end processes from inventory and assessments to remediations and final dispositions. Define and implement risk-based validation activities. Review and approve test plans, systems, and UAT test scripts.

Nice to Have: Recent experience with acquisitions, separations, or divestitures within a similar organizational environment.

• Computer System Validation
• M&A Data Migration
• Infrastructure Qualification
• Data Platform Domain
• GxP Standards
• Risk Based Validation
• QA Methodologies
• UAT Testing

For applications and inquiries, contact:View email address on click.appcast.io