Commissioning & Qualification Engineer (12 Months
6 days ago
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.
**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 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.
**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.
- 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.
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