Validation Engineer Role Cork

Validation Specialist

  • Posted Oct 17, 2022
  • Cork
  • Contract
  • BBBH25783

LSC have a great contract opportunity for Validation Specialist to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.

If you have 5+ years' experience in a cGMP regulated manufacturing environment and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Developing validation plans and rationale for process, packaging and shipping validation activities.
  • Responsible for shipping validation of products through the various GMP manufacturing nodes across BioMarin
  • Execute (protocol generation, execution, and final package preparation and reports) validation activities related to shipping validation.
  • Lead and represent MSAT Validation in multi-departmental meetings & project teams.
  • Assist with preparation of regulatory filings, responding to questions from regulatory agencies, and with presentation of materials during regulatory inspections /partner audits.
  • Participation in the change control program for modifications to qualified processes.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • Organizational and management skills to coordinate multi-discipline project groups
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.

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 opportunity!

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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