- Commissioning, Qualification & Validation (CQV) Specialist
Description:
We are seeking a CQV Specialist to support commissioning, qualification, and validation activities for pharmaceutical manufacturing and packaging systems in a GMP-regulated environment. This role will support equipment qualification, process validation, and related validation lifecycle activities for commercial manufacturing operations involving vial and prefilled syringe products.
The ideal candidate is a self-motivated professional who can quickly integrate into an active project environment, work independently, and proactively drive validation activities to completion. This position requires strong technical skills, effective communication, and the ability to coordinate with multiple functional groups in a fast-paced manufacturing setting.
Responsibilities:
- Support commissioning, qualification, and validation activities for pharmaceutical manufacturing and packaging systems.
- Develop and execute validation documentation, including Validation Project Plans (VPPs), validation strategies, risk assessments, Operational Qualifications (OQs), Process Performance Qualification (PPQ) protocols, and summary reports.
- Support qualification and validation activities for automated inspection systems, labeling systems, conveyors, and other manufacturing and packaging equipment.
- Participate in process risk assessments, product knowledge evaluations, and Failure Modes and Effects Analysis (FMEA) activities.
- Execute protocol testing activities, collect data, document results, and support field verification efforts.
- Identify protocol discrepancies, investigate issues, and provide recommendations to support timely resolution.
- Work closely with process engineers, project managers, manufacturing personnel, and quality teams to coordinate validation activities and project deliverables.
- Support deviation investigations, change controls, and validation documentation updates as required.
- Provide regular communication regarding validation progress, risks, and project status to affected stakeholders.
- Ensure validation deliverables comply with cGMP requirements and internal procedures.
- Perform other validation-related activities as needed to support business objectives.
Qualifications:
- Bachelor's degree in Engineering, Biology, Chemistry, Microbiology, or other related scientific discipline.
- 3 to 10 years of CQV, validation, or quality engineering experience within a pharmaceutical, biotechnology, or medical device manufacturing environment.
- Experience supporting equipment qualification and process validation activities.
- Experience developing and executing validation documentation
- Experience with manufacturing equipment, packaging equipment, automated inspection systems, labeling systems, or similar GMP-regulated technologies is preferred.
- Working knowledge of risk-based validation approaches and FMEA methodologies.
- Strong understanding of cGMP regulations, FDA guidance, and validation lifecycle principles.
- Strong technical writing, organizational, and communication skills.
- Demonstrated ability to work independently, manage multiple priorities, and proactively drive assignments with minimal supervision.
- Ability to work effectively in a fast-paced project environment and collaborate with cross-functional teams.
- Ability and willingness to work on-site in a manufacturing environment.
