LSC have a great contract opportunity for a Clean Utilities Engineer to join a global Biopharmaceutical company in Cork. The facility specializes in the fermentation, purification, and sterile filling of biotech products, as well as supporting product development and clinical trials.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Be responsible for adherence to site and corporate QMS for clean Utility Systems
- Support audits on clean utility systems.
- Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses.
- Complete periodic reviews and other compliance documentation aligned with the site QMS.
- Review and approve Utility & HVAC modifications, change requests, and SOP's.
- Conduct life cycle analysis of all critical system equipment to ensure equipment is upgraded and replaced in accordance with the Site Master Plan
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Degree or 3rd Level Qualification (Engineering), Masters preferred.
- Desirable to have qualification in Reliability Engineering and/or Project Management.
- Strong Compliance Mindset, demonstrated capability of understanding EHS & GMP compliance requirements (particularly from an Engineering perspective), demonstrated capability within the Audit environment (specifically EHS & GMP)
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Peter Cronin at +353 21 4777329 if you have any more questions about this opportunity!