Description
Role - Commissioning & Qualification Engineer - UtilitiesType - initially 12 month contract
Location - Co. Limerick
One of our key clients, a global leader within bio-pharmaceuticals, is looking for a number of C&Q Engineers with experience of Utilities.
Key Responsibilities:
• System P&ID walk down with construction prior to handover. Categorisation of punch list items & tracking to completion. Acceptance of system at mechanical completion (M/C).
• Generate method statements, risk assessments & permit preparation for responsible areas from M/C to handover to site operations.
• Pre-start safety checks, lockout & tag out & ensuring timely loop checking post-handover.
• Co-ordinate and supervise third party vendors during SAT execution. Review and approve SAT protocols.
• Generation, review and approval of commissioning protocols.
• Execution of the system commissioning protocols, Installation & Operation Qualification protocols, Process Qualification protocols (where applicable) following GDP guidelines.
• Ensure non-conformances & deviations are minimised and closed out with Engineering and QA Validation in a timely fashion.
• Ensuring that punch list items are documented, tracked, expedited and resolved by system handover to site operations.
• Attend daily communication meetings with area lead and report progress.
• May supervise mechanical, electrical, and automation contractors.
• Assists in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
• Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
Key Requirements:
• BSc/BEng or higher in chemical/biochemical or mechanical engineering
• Advanced knowledge of cGMPs and sanitary equipment operating requirements.
• Working knowledge of process control systems and automation. Allen Bradley PLC experience beneficial.
• Advanced knowledge of C&Q documentation required for cGMP process equipment.
• Substantial knowledge of clean room operation & function and of biopharmaceutical equipment.
• Strong written and oral communication skills.
• Ability to understand project plans and schedules.
• Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
• Direct experience with biopharmaceutical utilities.