CQV Engineer

• Support the Sterile Drug Product Facility project as part of the CQV team.
• Develop and execute commissioning and qualification plans for new and existing equipment and systems.
• Perform equipment and system start-up activities, including functional testing and troubleshooting.
• Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Develop and execute validation protocols to support facility/utilities, equipment and computer systems validation.
• Ensure that validation activities comply with regulatory requirements (e.g., FDA, EMA, ICH) and industry standards (e.g., GAMP 5).
• Maintain validation documentation and ensure it is up-to-date and audit-ready.
• Identify opportunities for process improvements and implement changes to enhance efficiency and compliance.
• Participate in root cause analysis and corrective/preventive action (CAPA) processes.
• Work closely with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, MS&T Process and Regulatory Affairs.
• Communicate validation plans, progress, and results to stakeholders.

• The candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline.
• Previous CQV experience is an advantage, previous GMP experience is essential.
• The ideal candidate would have biopharmaceutical Process / Validation knowledge.
• Exposure to cGMP in a fast-paced environment is required.
• Previous experience in working in a drug product filling facility would be advantageous.

Morgan McKinley