Description
A C&Q Engineer is required to join the Facility Services Project team in a Biologics Drug substance manufacturing facility.The candidate requires experience in Buffers/ Media prep or bioreactors and downstream - general qualification to ramp up and get the project completed.
The successful candidate will be able to demonstrate a proven track record to take systems from the Construction Handover stage and carry them through the Commissioning and Validation cycle and into Performance Qualification to allow handover to Manufacturing.
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.
* Liase 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.
Requirements:
* 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