Maintenance Engineer Role Dublin

Cleaning Validation Technical Specialist

  • Posted Jul 6, 2022
  • Dublin
  • Contract
  • BBBH25419

LSC have a great contract opportunity for Cleaning Validation Technical Specialist to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development, and commercialization of life-transforming therapeutic products.

If you have Minimum 5 years' experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and to liaise closely with Operations/QC to oversee the design and execution of studies (as required).
  • Identify and implement improvements where feasible.
  • Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to typical BDS manufacturing areas. Temporary shift working may be required during periods of engineering batch and validation batch execution, and participation in on-call roster.
  • Provide on the floor support for troubleshooting cleaning related issues and may lead manufacturing investigations into process deviations.
  • Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities.
  • Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • Technical and operational knowledge of cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities.
  • Experience of cleaning validation is a must, and/or cleaning approaches to multiproduct is advantageous.
  • Experience of cleaning verification/validation of downstream processing equipment (Chromatography skid, UFDF/TFF skids, Filtration skids, and process hold vessels).

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!

Apply via this advert or contact Sarah Ninan at LSC on 021-4777329 if you have any more questions about this role!

This could be the perfect project for you! Apply online and we’ll be in contact shortly

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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