Description
We are currently recruiting for Commissioning & Qualification Engineers to be based in Ireland for a minimum of twelve months to Commission and qualify biopharmaceutical process equipment to project technical specifications.Essential Duties and Responsibilities include, but are not limited to, the following:
• 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.
• 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.
• Maintains a clean and safe working environment by enforcing procedures, policies, and regulations.
Knowledge and Skills:
• 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.
• Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
Education and experience:
• Requires BSc/BEng or higher in chemical/biochemical or mechanical engineering
• 5-10 years of related experience open to sterile, bio or fill finish environments.
• Direct experience with biopharmaceutical utilities and process equipment is preferred
• Media buffer prep
Please do apply for more details.