Commissioning, Qualification & Validation (CQV) Specialist

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.