Position : CQV Specialist
Location: New Jersey
Experience: 5+ Years
Industry: Pharmaceutical / Biotechnology Job Description We are seeking an experienced
CQV Specialist to support commissioning, qualification, validation, and lifecycle management of laboratory equipment at a leading pharmaceutical organization in New Jersey.
The ideal candidate will have hands-on experience with QC laboratory equipment qualification, particularly
Temperature Control Units (TCUs), along with IQ/OQ/PQ protocol development and execution. This role requires a strong understanding of GMP compliance, FDA regulations, data integrity, and equipment validation practices. Key Responsibilities - Lead commissioning, qualification, and validation activities for newly installed QC laboratory equipment, with a primary focus on TCU equipment and associated laboratory systems.
- Develop, review, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Perform equipment qualification and method qualification activities for newly installed laboratory instruments and analytical equipment.
- Prepare and maintain validation documentation, including protocols, test scripts, execution records, deviation reports, and final qualification reports.
- Support laboratory software upgrades, system enhancements, and change control activities while ensuring equipment remains in a validated state.
- Coordinate equipment decommissioning and retirement activities for legacy laboratory systems in accordance with GMP and company procedures.
- Ensure all CQV activities comply with FDA regulations, cGMP requirements, data integrity principles, and applicable industry standards.
- Collaborate with QC, Engineering, Quality Assurance, and cross-functional teams to support laboratory qualification and compliance initiatives.
Required Qualifications 5+ years of experience in Commissioning, Qualification, and Validation (CQV) within a GMP-regulated pharmaceutical or biotechnology environment.
- Hands-on experience developing and executing IQ/OQ/PQ protocols for laboratory and analytical equipment.
- Experience with TCU equipment, temperature control systems, and QC laboratory instrumentation is highly desirable.
- Strong understanding of FDA regulations, cGMP requirements, data integrity, and equipment validation lifecycle practices.
- Experience supporting analytical laboratory instruments, computerized systems, and laboratory software validation activities.
- Knowledge of change control, deviation management, validation documentation, and equipment lifecycle management.
- Strong technical writing, documentation, troubleshooting, and cross-functional communication skills.