6498 - Senior CQV Engineer / Senior Validation Engineer

Senior Validation Engineer Responsibilities:

• Lead and/or support the execution of CQV activities for facilities, utilities, manufacturing equipment, laboratory systems, and computerized systems within GxP-regulated environments.
• Author, review, and execute CQV documentation, including URS, risk assessments, qualification plans, protocols, test scripts, IQ/OQ/PQ documentation, commissioning documents, deviations, and validation/qualification summary reports.
• Develop and execute qualification and testing activities, including IQ/OQ/PQ, functional testing, system walkdowns, field verification, punch-list management, and acceptance testing.
• Coordinate and perform hands-on field execution, ensuring protocols are followed, test results are properly documented, and discrepancies are identified, investigated, and resolved.
• Work with Engineering, Quality, Operations, Automation, and vendors to coordinate commissioning and qualification schedules, test execution, system readiness, and project deliverables.
• Review engineering and vendor documentation, drawings, specifications, manuals, and test records to support CQV planning and execution.
• Ensure CQV deliverables and execution activities comply with cGMP, GAMP 5, ASTM E2500, data integrity principles, and applicable regulatory requirements.
• Manage and support deviations, discrepancies, change controls, and corrective actions associated with commissioning and qualification activities.
• Maintain accurate documentation and ensure all executed records meet Good Documentation Practices (GDP) and client quality requirements.
• Provide technical guidance and mentorship to junior CQV engineers and support the development of standardized CQV processes and templates.
• Communicate project status, risks, issues, and deliverable progress to project and functional leadership.
• Support multiple projects and priorities while maintaining quality, schedule, and execution commitments.

Job Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 5+ years of hands-on CQV experience within pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
• Demonstrated experience with both authoring and field execution of CQV/qualification documentation.
• Strong experience developing and executing IQ/OQ/PQ protocols, commissioning documentation, test scripts, and qualification reports.
• Experience with facilities, utilities, manufacturing equipment, laboratory systems, and/or computerized systems.
• Strong understanding of cGMP requirements and the equipment/system qualification lifecycle.
• Experience with deviation management, change control, punch-list management, and resolution of qualification issues.
• Strong technical writing, documentation, organizational, and problem-solving skills.
• Experience leading CQV activities or workstreams within large pharmaceutical or biotechnology capital projects.
• Experience with GAMP 5, ASTM E2500, risk-based qualification approaches, and data integrity/ALCOA+ principles.
• Experience working with engineering drawings, P&IDs, equipment specifications, and vendor documentation.