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Senior Process Engineer Biotechnology

Location: Singapore
Company: NO DEVIATION PTE. LTD.
Freshteam
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The position includes responsibility for all or part of the following steps :
  • Follow the basic and the detailed design and manufacturing of the equipment for mechanical, automation and single use parts
  • Develop process equipment and respective datasheet including EHS aspect
  • Define layout of manufacturing suite
  • Define cleaning and sterilization strategy
  • Address C&Q strategy
  • Review URS issued by the Engineering Office
  • Participate to the bidding phase
  • Provide technical recommendation during supplier selection phase
  • Approve design documents
  • Collaborate with QA and supplier to issue appropriate design GMP documents
  • Drive process review with automation engineer (Marked up P&IDs, FS, FDS,…)
  • Travels to suppliers premises for audit and technical discussion
Required Experience & Knowledge
  • Minimum of 5-10 years experience in the pharmaceutical industry, engineering contractors
  • Experience in single use assemblies design and use
  • Experience of qualification and validation techniques and cGMP requirements
  • Experience in different production scale with primary equipment (Fermenters, disk stack centriguge, precipitation, High pressure homogenizer, ultrafiltration, chromatography, buffer preparation vessels,…)
  • Good organizational skills and ability to manage his time and identify priorities
  • Good reactivity when facing challenges
  • Flexible for travel 20%
  • Challenge planning and users decisions
  • Automation and single use qualification experiences are an asset


EA License No : 19C9587
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