Description
We are seeking an experienced CQV Engineer to support the commissioning, qualification, and validation of GMP systems in a regulated manufacturing environment. The ideal candidate will have hands-on experience with manufacturing processes, aseptic fill/finish operations, compressed air systems, and a thorough understanding of FDA regulatory requirements (cGMP, 21 CFR Part 11).
Key Responsibilities:
- Lead end-to-end Commissioning, Qualification, and Validation (CQV) activities for equipment and utility systems, ensuring compliance with site procedures, cGMP principles, and regulatory expectations.
- Provide expertise in VP, URS, system classification, and risk-based validation strategies to define appropriate qualification pathways for new and existing systems.
- Responsible for the qualification of systems such as pumps, batching tanks, transfer panels, HMIs, boiler, feedwater tank, compressed air, and computerized systems etc., ensuring traceability from design through to PQ.
- Execute and support Performance Qualification for processes such as computer system validation, bulk hold time validation, and cleaning/changeover activities.
- Develop and review technical documentation, including URS, risk assessments, validation protocols (IQ/OQ/PQ), summary reports, and the Equipment & Utility Validation Master Plan (VMP).
- Facilitate and contribute to FMEA risk assessments, worst-case product grouping evaluations, and cleaning validation strategies as part of the overall lifecycle approach.
- Deliver training and mentoring to the client employees on equipment validation, lifecycle concepts, risk-based validation, and documentation best practices.
- Ensure alignment with project timelines by coordinating validation deliverables across functions (QA, Engineering, Operations, compounding), while maintaining validation traceability and audit readiness.
Requirements
- Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related discipline).
- 8-10 years of CQV experience in the pharmaceutical, biotech, or medical device industry.
- Strong knowledge of GMP environments, FDA regulations.
- Hands-on experience with:
- Aseptic manufacturing and filling lines
- Compressed air systems (ISO 8573-1 standards)
- Cleanroom environments and clean utility systems
- Proficient in validation documentation and electronic quality systems.
- Excellent communication, organization, and technical writing skills.
- Ability to manage multiple priorities and work both independently and within a team.
Preferred Qualifications:
- Experience with project-based environments (facility expansions).
- Familiarity with validation lifecycle approaches and computerized system validation (CSV).
- Lean/ Six Sigma certification is a plus.
Benefits
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
