Commissioning & Qualification Engineer - Carlow, Ireland
Natasha Young at CK Group is recruiting for a Commissioning & Qualification Engineer to join a company in the Pharmaceutical industry at their site based in Carlow, Ireland on a contract basis for 12 months.
The Company: Our client has a long history of pushing the boundaries of science in order to help fight some the worlds most urgent global health challenges. This role is based at a state of the art biologics operation where they formulate and fill vaccines and biologic products.
The Location: The role is based at our client's site in Carlow, Ireland. Carlow is a fascinating town which pre dates written Irish history, has played a major part in Irish history and even served as the capital of the country in the 14th century.The Role: The Commissioning & Qualification Engineer manage part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on a multi-product facility. The successful candidate will take systems from the Concept Stage through Construction Handover stage and carry them through the Commissioning and Validation cycle to allow handover to Manufacturing. This role will work cross functionally and coordinate activities between Construction, Process, Technical Operations and QA.
Key Responsibilities include:
- Lead and coordinate a commissioning and qualification program, incorporating Clean Utilities(including CIP), syringe ling, vial line and associated upstream operations.
- Assist the C&Q manager in the planning and tracking of activities.
- Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
- Oversee the generation, execution and approval of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
- Generate C&Q change controls and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
- Perform system P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion.
- Ensure that system delivery progresses in accordance with the approved project schedule.
- Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.
- Ensure the cohesive operation of cross-functional team and coordinate work for effective and efficient completion.
Your Background: To succeed in this role, you will have a proven track record to take systems from the Concept Stage through Construction Handover. You will have advanced knowledge of C&Q documentation required for cGMP process equipment, working knowledge of process control systems and automation, knowledge of regulations and standards affecting devices, biologics and pharma products. DeltaV, syringe & vial line experience would be extremely beneficial.
For more information or to apply for the Commissioning & Qualification Engineer position, please contact Natasha Young on 01246 457739 or email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA44237 in all correspondence.