Cq Engineer

1 day ago


Singapore No deviation Pte Ltd Full time

**Project Background**:
The scope of this project is to build an API facility, including an organic synthesis plant, milling building, solvent tank farm, warehousing, thermal oxidiser, laboratories, offices and canteen facilities. The project is currently concluding the detail design phase with construction activities underway.

**Purpose of the Role**:
In this CQ Engineer role, the individual will work within a C&Q team consisting of a CQ lead and two CQ engineers providing oversight to a third party commissioning team in the Warehouse/Dispensary/Drumstore and QC Lab. Primary responsibility will be to provide technical oversight on behalf of the company 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

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 team and this role includes execution of the company IQs and OQs during the Qualification effort.

**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.

**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.

**EA Reg. No**: R2094147 | EA License No: 19C9587



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