This Commissioning & Qualification Engineer will be required to prepare and execute C&Q documentation in accordance with the project CQ program. They will work closely with the equipment group C&Q Lead to make sure the C&Q schedule and program requirements are being met for the systems under their ownership and any exceptions are identified and addressed.
Role Responsibilities
Abide by all safety requirements and procedures and serve as a positive model to others in this regard. Re-enforce in meetings, perform periodic field observation and feedback as needed to ensure safe and compliant delivery of commissioning and qualification activities.
Provide a strong working technical knowledge of utility and process systems regarding the development of protocols, their execution, and close out.
Track and report progress to the Equipment Group C&Q lead as required in support of the agreed C&Q metrics.
Prepare and execute C&Q documentation in accordance with the project C&Q program.
Work collaboratively with the other project disciplines (e.g. automation, construction, engineering, end user) to support integration of activities.
Review and acceptance of contractor and vendor handover documentation for Mechanical Completion Acceptance.
Running control modules, equipment modules, phases etc. via a DCS system.
Vendor and contractor coordination and supervision.
Role Requirements:
BS Engineering (or equivalent experience)
5 years CQ experience in pharmaceuticals or biologics. This is a pharmaceutical plant and knowledge and experience of unit operations in pharmaceuticals is preferential.
In-depth equipment commissioning and startup knowledge and experience with strong troubleshooting skills.
GMP knowledge is required as Installation and Operational Qualification execution is included in the role. This is not, however, a validation role.
Working knowledge of DeltaV automation systems.
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