We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
• 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
• Represent the Utilities engineering group and lead highly technical cross-functional teams and work across utilities engineering areas to deliver robust and sustainable solutions and business processes.
• The primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems).
• Drive functional commitments on initiatives and provide high level of oversight and coordination to seamlessly integrate utility engineering efforts within the site.
• Consult with other subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny.
• Act as the utilities engineering expert and technical consultant to management in identifying opportunities, prioritizing work and will make sound recommendations for design and construction solutions.
Education & Experience
• Relevant experience in pharmaceutical production management.
• Degree or 3rd Level Qualification in Engineering
• Desirable to have qualification in Reliability Engineering and/or Project Management.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.