Job Description: We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical, biotechnology, or life sciences manufacturing facilities. The role will support equipment, utilities, facilities, and manufacturing systems while ensuring compliance with GMP, FDA, GxP, and applicable industry standards.
Responsibilities: - Lead Commissioning, Qualification & Validation (CQV) activities for manufacturing equipment, utilities, facilities, and systems.
- Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation and protocols.
- Develop CQV plans, validation strategies, protocols, reports, and traceability documentation.
- Review engineering specifications, P&IDs, drawings, equipment documentation, and vendor packages.
- Coordinate and execute FAT/SAT activities with vendors, Engineering, Quality, and project teams.
- Perform equipment and utility qualification activities in accordance with approved procedures.
- Develop and execute risk assessments, including FMEA and criticality assessments.
- Ensure validation activities are aligned with GMP/GxP, FDA, EU GMP, GAMP 5, and ISPE requirements.
- Support commissioning activities and transition systems from construction through qualification and operational readiness.
- Manage deviations, discrepancies, change controls, and CAPA associated with CQV activities.
- Perform root cause analysis and implement appropriate corrective and preventive actions.
- Review and approve test results, qualification packages, and validation reports.
- Coordinate with Engineering, Automation, Manufacturing, Quality Assurance, Facilities, and external vendors.
- Provide technical leadership and mentoring to junior CQV engineers.
- Support project schedules, resource planning, and CQV deliverables.
Requirements: - Bachelor's degree in mechanical, Electrical, Chemical, Biomedical, Pharmaceutical, or related Engineering discipline.
- Typically, 7-10+ years of CQV/validation experience in pharmaceutical, biotech, medical device, or other regulated industries.
- Strong knowledge of GMP/GxP validation requirements.
- Excellent technical writing, communication, leadership, and problem-solving skills.
