Leading biopharmaceutical CDMO are continuing to expand their Irish operation by establishing a new state-of-the-art facility in north Leinster. A vacancy has now arisen for an experienced CQV Lead Engineer with specialisation in clean utilities. This site will manufacture for global supply and is expanding in response to growing customer requirements.
If you are passionate about technology, enjoy the challenge of working in a start-up environment and are ambitious this is a fantastic opportunity to join a rapidly expanding organisation.
As a lead within the CQV Department you will report to the Utilities CQV PM and oversee the work of a small group of professionals. This is a challenging position and will require flexibility and creative approaches to problem solving.
- Manage approvals for CQV Documentation relating to HVAC, compressed air, water systems, CA, CS, PW, WFI, loop and CIP/SIP.
- Oversee generating approvals and the management of GMP documentation.
- Track and review all executed copies before submission to QA Dept.
- Act as SME on deviation resolutions across the clean utilities network.
- You will work closely within this group and liaise with multi-disciplinary teams on-site to deliver effectively against the business' objectives.
- Assist with investigations of equipment, utility and control systems as required.
- All applications must have a Degree in Engineering with a minimum of 5 years' experience within a GMP manufacturing environment.
- The right person will be an expert in Clean Utilities systems - WiFi, Clean Steam, gas systems.
- A strong communicator with the ability to work well within a cross-functional team to achieve a common objective.
- Collaborative approach to work and a positive attitude will be a good fit with this team dynamic.
- Thorough knowledge of safety, GMP and environmental regulatory requirements around site utilities systems
- Demonstrated capability within an audit environment (specifically EHS and GMP).
To discover more about this opportunity, apply now or contact Aisling Clements at HRM on +353 87 752 1041 for a confidential discussion.