Summary: Commissions and qualifies biopharmaceutical process equipment to project technical specifications.
Essential Duties and Responsibilities include, but are not limited to, the following:
 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.
 Pre-start safety checks, lock out & tag out & ensuring timely loop checking post handover.
 Coordinate 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 punchlist 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.
 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.
 Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
Education and experience:
 Requires BS/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.

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