Description
Our client is a global pharmaceutical organisation that requires a C&Q Engineer for a 6 month contract role, based in Ireland. Their API Manufacturing facility is going through a major investment programme that has resulted in a major plant modification project.Role related Activities:
* The Commissioning & Qualification Engineer is responsible for commissioning and operational qualification (OQ) of applicable projects / changes and production support of Performance Qualification (PQ) activities.
Specific Tasks, Responsibilities:
* Generation of list of C&Q tests (Installation Verification (IV), Operational Verification (OV), Operational Qualification (OQ), Performance Testing (PT) and Performance Qualification (PQ)
* Execution of process commissioning & qualification tests in adherence with project schedule and under the direction of the process commissioning manager
* Accepts turnover of equipment / system from construction group.
* Ensures commissioning execution is in accordance with GEP.
* Approval of non-quality related critical process parameters for commissioning.
* Review of the Installation Check (IC) documentation
* Post-approval of the IC Report
Specific Tasks, Responsibilities:
* Work within a cGMP environment.
* Work within the safety and environmental regulations as they apply to this industry.
* Work outside normal hours may apply occasionally.
Skills/Experience required:
* API Process equipment preferred but not essential - what is essential is protocol generation and hands on execution experience
* Equipment experience on Reactors, Centrifuge, Dryers & Pack off.
* Plant utilities such as Steam, Hot water, Cooling tower water & LTC.
* RS3 and//or PCS 7 experience.
Please apply now for more information!