Description
C&Q Engineer required to join a team in a Biologics Drug substance manufacturing facility in South West Ireland. The commissioning engineer will be responsible for taking systems from the Construction Handover stage and carry them through the Commissioning and Validation cycle and into Performance Qualification to allow handover to Manufacturing. The candidate must be a convincing communicator with strong interpersonal skills, to lead a team of Commissioning and validation engineers.RESPONSIBILITIES:
* Lead and co-ordinate a commissioning and qualification program, incorporating utilities, upstream and downstream manufacturing equipment and support services such as autoclaves, parts washers and cold rooms.
* Assist the commissioning manager in the planning and tracking of activities.
* Liaise with the various stakeholders on the commissioning team and the overall project to ensure clear communication between all parties.
* Provide technical process support to the commissioning team throughout the project life cycle.
* Oversee the generation, execution and approval of Commissioning & Qualification documentation.
* Generate change controls and drive their closure in a timely manner
* Responsibility for direct supervision of vendor engineers and contractors during C&Q activities.
* Use of permit to work system or other safety systems to control commissioning activities.
* Participation in HAZOP and design reviews
* Deliverables such as technical specifications and vendor turnover documentation
EDUCATION AND EXPERIENCE:
* Minimum of an Engineering Degree with 8+ years experience working as a C&Q engineer in a Bio-Pharmaceutical or equivalent type industry
* Demonstrated experience in leading qualification systems
* Technical knowledge of utilities, upstream & downstream equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred
If this is you, please apply today.