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Equipment Qualification Lead

  1. Midlands (Ireland)
Limerick
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
08-11-2023
32604

This vacancy has now expired

Equipment Qualification Lead - Biopharma - Limerick - 12-Month Contract

We are recruiting on behalf of a leading global pharmaceutical client based in the stunning surroundings of Limerick. Due to a large capital investment and multiple projects on site, the client is looking for an Equipment Qualification Lead with to join their team.


Key Responsibilities:   

Role will initially support start up activities with design of strategies for temperature control units (TCUs) e.g. walk in and upright freezers, cold rooms, working cell bank, incubators, lab freezers, as required.
  • User rep for design and operation of all temperature-controlled units (TCUs) in the Limerick site.
  • Design control strategy including alarm rationalisation, monitoring and response for all temperature-controlled storage areas.
  • Interact with Development to influence early molecule storage considerations for manufacturing.
  • Support Mapping Studies to ensure temperature mapping is integrated into control strategy for required product interactions movement e.g.  shipping, unloading and loading freezers
  • Define the business processes for temperature-controlled unit interactions including work instructions, procedures etc
  • Support FMEAs, safety risk assessments, Job Hazard Assessments on introduction of walk-in freezers / cold rooms 
  • Work with business partners, procurement and vendors to build robust SLAs and develop preventative maintenance programme for onsite TCU’s
  • Design & influence paperless system for product movements to ensure all moves are executed according to while maintaining paperless approach.

Educational/Experience Requirements:
  • BSc/MSc Engineering or related discipline with a minimum of 5 years pharmaceutical experience.

If you are local to Limerick and interested in discussing this position, please apply now!



The candidate must have the rights to work in the location stated in the job advert.

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