Commissioning, Qualification and Validation (CQV) engineer for various capital and Equipment/Clean Utilities lifecycle projects joining a dynamic team. Ensure the activities are completed safely, as per schedule and in compliance with GMP and Quality Requirements. This role will be responsible for equipment validation in Sterile Fill Finish to ensure the maximum levels of performance and compliance are maintained.
Key Responsibilities:
- Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process from initial design through qualification to validation maintenance (eg. Periodic review)
- Coordinates the qualification activities and maintain Equipment and utility systems in a validated state
- Development or qualification approaches and equipment family strategies
- Assist in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
- Development and approval of C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQ's, PQ's etc. for the Vial and Syringe filling, formulation, inspection and clean utility areas in line with GMP's, regulatory requirements and corporate standards.
- Assist in assessment of project change controls ensuring Validation standards & requirements are met.
- Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment User Requirement Specifications, Factory Acceptance Tests to ensure the quality by design principles are being followed.
- Assist in the development and improvements of the equipment validation lifecycle process while ensuring continued compliance to all necessary regulations.
- Participate in regulatory inspections, regulatory filings and RTQ's (response to questions).
- Update and maintain Standard Operating Procedures (SOP's) in accordance with site and corporate requirements.
- Take ownership for quality compliance in all activities you are responsible for, Ensuring approaches are aligned with current guidelines (ICH/ASTM)
- Ensure the site change control procedure is adhered to.
Education / Experience:
- 6+ years experience in Science, Engineering or Validation, Commissioning and Qualification Management
- Technical qualification at third level or equivalent in Engineering or science.
- Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects
- Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry
- Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
- Experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product.
- Knowledge of safety, GMP and environmental regulatory requirements.
- Participate, when required, as a member of a multidisciplinary site and multisite teams, e.g. Cross Functional Investigation Team or NPI regulatory marketing applications.
