The Commissioning & Qualification Engineer's responsibility will be to provide technical oversight on behalf of client of a third party commissioning team responsible for the C&Q efforts in the Warehouse/Dispensary/Drumstore Buildings. The primary equipment in the Warehouse/Dispensary/Drumstore consists of three Dispensaries, a Subdivision Suite and Sampling Suite, a Cold Room and Freezer Room and a High Bay Warehouse. The QC lab equipment consists primarily of Fume Hoods, Glass Washers, Incubators, MilliQs, Fridges and Freezers
There a number of vendor PLC controlled equipment items in the Warehouse/Dispensary/Drumstore and QC Lab and strong vendor management experience will be required in this role to ensure smooth execution of vendor’s Site Acceptance Testing.
The role includes C&Q execution on other process equipment as required and is not exclusive to the Warehouse/Dispensary/Drumstore and QC Lab.
Systems in the Warehouse/Dispensary/Drumstore and QC Lab that are classified as Direct Impact will undergo Qualification by the Pfizer team and this role includes execution of IQs and OQs during the Qualification effort.
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 technical oversight to assure technical work quality and consistent delivery of C&Q in accordance with the project C&Q program.
Provide a strong working technical knowledge of utility and process systems regarding the development of protocols, their execution, and close out.
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.
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.
Experience in the management of vendors for Site Acceptance Testing.
Demonstrated people management 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.