Description
World leading Biopharmaceutical plant, based in Ireland,have a number of opportunities for CQV Engineers. Working on a €400million Greenfield project, we are looking for experienced CQV Engineers to work on the installation and qualification of a new Upstream & Downstream suite.This is a 12 month + contract position and we are seeking experienced engineers with equipment experience of either: Fermentors, harvest trains, chromatography, filtration, purification etc
Duties will include:
• System P&ID walkdown with construction prior to handover. Categorisation of punchlist 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.
• 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.
• Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
Knowledge and Skills:
• 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.
Education and experience:
• Requires BSc/BEng or higher in chemical/biochemical or mechanical engineering.
• 5-10 years of related experience
• Direct experience with biopharmaceutical utilities and process equipment is preferred
• May substitute relevant experience for education