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Autoclave Lead- CD/ PQ

  1. Dublin
  1. Contract
Competitive
23710 JL
  1. Commisions, Qualification and Validation
Date Posted22 Nov 2019

This vacancy has now expired

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 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
Desirable Experience:
  • 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.
 If you have extensive Autoclave and Cycle development experience, please apply now.

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