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Manufacturing Engineer - Biopharmaceutical - Dublin

  1. Dublin
  1. Contract
Competitive
23475WP
  1. Life Sciences
Date Posted20 Nov 2019
Newly constructed state-of-the-art biologics drug-substance manufacturing facility based in Dublin have a long term contract assignment for an experienced Manufacturing Engineer.

Working within mammallian cell culture operations we are looking for a Manufacturing Technology Engineer who has experience of downstream processes.

You will be involved in the process validation & process technical support to cell culture, purification and ultrafiltration/diafiltration unit operations for the commercial manufacture of mammalian cell processes in the Multi Product Cell Culture facility. 

Key Responsibilities:
  • Investigation process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings
  • Strong knowledge of cGMP compliance 
  • Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
  • Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the Cruiserath Multi Product Cell Culture facility.

Experience required for this role:
  • Minimum BSc or equivalent with at least 4 years’ industry experience
  • Downstream / Purification manufacturing technical support in the biopharmaceutical industry including experience with process validation
  • cGMP compliance & regulatory requirements
  • Excellent communication & technical writing skills.

Lovely client to work for & excellent working environment! Call me for more information on this role. 




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