We are partnering with a leading global life sciences company constructing a €330m greenfield biopharmaceutical facility in Kerry. This state-of-the-art, highly sustainable plant will focus on the aseptic fill-finish and lyophilization of advanced biologics (mAbs and ADCs) and is now seeking a CSV Engineer contractor to join the team.
The Role:
- Lead the validation of computerized systems, including the development and execution of Validation Plans, IQ/OQ/PQ protocols, and Summary Reports, specifically tailored to sterile manufacturing equipment.
- Drive and implement system-related improvements to ensure predictable performance across core production areas, with a heavy emphasis on aseptic processing/filling, lyophilization (freeze-drying), and fill-finish systems.
- Ensure data integrity and risk reduction across automated platforms, aligning manufacturing execution systems and equipment software with ALCOA+ principles and regulatory expectations.
- Provide effective and responsive CSV support to Operations, Automation, and IT to meet site objectives regarding quality, regulatory compliance, and system uptime.
Required:
- Degree in Engineering or a Scientific related discipline.
- 5+ years of experience in a Pharmaceutical or Medical device manufacturing environment (must be GMP regulated).
- Strong background in aseptic processing, sterile fill-finish, compounding, or lyophilization technologies is highly desirable.
