Autoclave Lead- CD/ PQ
Our biotech client with manufacturing facilities just outside Dublin is currently investing significantly in their manufacturing programme. Building a state-of-the-art facility, utilising high-technology and next-gen processes to produce drugs that are distributed throughout the Globe. The site is easily reachable by a major airport and has excellent transport links throughout.
The client is currently seeking the expertise of An Autoclave CD/ PQ Lead. Essential Duties and Responsibilities for this Lead Autoclave Cycle development role include, but are not limited to, the following:
- The role envisaged is to lead the scope of work associated with Autoclave Cycle Development (CD), Recipe Configuration & PQ for a Biologics facility undergoing start-up.
- Managing a team of project & operations resources to safely deliver the scope of work, noting that the project resources will have completed the CQV scope associated with the equipment
- Development of CD/PQ plan / schedule and track progress, through Earned Value Measurement
- Development of CD protocols, Recipe Configuration Specifications (RCS) and PQ protocols (per load type & also for GMP Air Filter SIP)Ensure CD/PQ readiness
- Execute all CD/PQ protocols (CD runs, air detector runs, GMP air filter SIP runs and empty chamber & full chamber runs)
- Manage Biological Indictors (expiry, incubation etc.)
- Define & Configure Loads (including rack modification if required)
- Prepare Loads for all the cycle runs
- Temperature Map (KAYE equipment – 2 validators to allow for parallel activities
- Experience across Porous, Liquid loads and decontamination and laboratory autoclaves.
- Requirement to have successfully undertaken a similar project management role previously
- Demonstrable project management experience in a regulated environment
- Excellent communication skills (written and oral).
- Excellent collaboration skills and teamwork mind-set.
- Excellent trouble shooting and problem-solving skills, as well as an ability to work through complex problems.
Do you relish the opportunity to work with a leading Irish based Biologics manufacturer? If yes, then this is the assignment for you! Our biotech client with manufacturing facilities just outside D
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