Description
Role - Commissioning & Qualification Engineer - UpstreamType - 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 Upstream process equipment.
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 and process equipment