We are seeking a CQV Engineer to join our clients team. Specializing in areas such as equipment, utilities and computer systems validation, the candidates will report to the Senior Manager, Engineering Commissioning, Qualification and Validation. The successful candidates will be part of the Sterile Drug Product Facility (SDPF) project working within the CQV team. This role involves developing and executing validation protocols, ensuring compliance with regulatory requirements, and supporting continuous improvement initiatives.
Key Responsibilities
- 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.
Qualifications & Experience
- 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.
