Commissioning, Qualification and Validation (CQV) Engineer for various capital and equipment/clean utilities lifecycle projects, joining a dynamic team. Ensure activities are completed safely, on schedule, and in compliance with GMP and Quality requirements. This role will be responsible for equipment validation in sterile fill finish operations to ensure maximum levels of performance and compliance are maintained.

Key Responsibilities:

• Provide expert technical validation support to meet site objectives, comprising the full validation lifecycle process from initial design through qualification to validation maintenance (e.g. periodic review).
• Coordinate qualification activities and maintain equipment and utility systems in a validated state.
• Develop qualification approaches and equipment family strategies.
• Assist in the development of User Requirement Specifications (URSs) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).
• Develop and approve C&Q/Validation Plans, FAT, SAT, IV/FTs, QRAES, IOQs and PQs for vial and syringe filling, formulation, inspection and clean utility systems in line with GMPs, regulatory requirements and corporate standards.
• Assist in the assessment of project change controls, ensuring validation standards and requirements are met.
• Liaise with Engineering, CQV, Manufacturing, Planning, Process Development, and external vendors regarding equipment URSs and Factory Acceptance Tests, ensuring quality-by-design principles are followed.
• Assist in the development and continuous improvement of equipment validation lifecycle processes while ensuring compliance with all applicable regulations.
• Participate in regulatory inspections, regulatory filings, and responses to regulatory questions.
• Update and maintain Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
• Take ownership of quality compliance in all assigned activities, ensuring approaches are aligned with current guidelines (ICH/ASTM).
• Ensure site change control procedures are adhered to.

Education / Experience:

• 6+ years' experience in Engineering, Validation, Commissioning, Qualification, or a related scientific discipline.
• Third-level qualification or equivalent in Engineering or Science.
• Extensive knowledge and demonstrated experience managing Commissioning and Qualification activities for pharmaceutical or biotechnology projects.
• Strong understanding of risk-based commissioning and qualification approaches within regulated manufacturing environments.
• Experience with sterile manufacturing equipment is preferred.
• Experience qualifying filling, formulation, and utility systems within sterile manufacturing environments.
• Knowledge of safety, GMP, and environmental regulatory requirements.
• Ability to work as part of multidisciplinary project teams and support cross-functional investigations, improvement initiatives, and new product introductions where required.