Senior Process Engineer Biotechnology
❮ back to last search| Location: | Singapore |
|---|---|
| Company: | NO DEVIATION PTE. LTD. |
- 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
- 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
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