Process Validation Engineer Role Cork

Process Validation Specialist

  • Posted Sep 26, 2022
  • Cork
  • Contract
  • BBBH25791

LSC have a great contract opportunity for Process 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.

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • In collaboration with plant support functions, assist with planning, set up and implementation of Process Validation programs.
  • Execute (protocol generation, execution, and final package preparation) process Validation activities related to Product Introductions and Change Control.
  • Develop process validation plans for specific projects.
  • Establish site process validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
  • Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.
  • Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.
  • Assist with preparation of regulatory filings and participation during regulatory inspections/partner audits.
  • Lead and represent GMSAT Process validation in multi-departmental meetings and project teams.
  • Identifies and implements improvements to the GMSAT Process validation systems.

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!

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