We are seeking a proactive, detail-oriented, and agile Biotechnologist to join our expanding Downstream Process (DSP) team at our state-of-the-art Singapore CRDMO Hub in Tuas. This role offers a unique, front-row seat to the operational setup, commissioning, and validation of a world-class biomanufacturing facility from the ground up.
Responsibilitie
- sPrepare equipment and materials; perform protein chromatography, filtration, packing, and transportation in compliance with GMP requirements
- .Execute cleaning activities in clean areas per GMP standards (periodic, changeover, and equipment cleaning)
- .Manage raw material ordering, tracking, and inventory control
- .Oversee process equipment/instrument lifecycle: ordering, qualification, validation, calibration, maintenance, and management
- .Draft and revise documents such as SOPs, MBRs, URS, FAT, and SAT
- .Review and update production records (BPR, logbooks, etc.)
- .Conduct environmental monitoring during bulk fill as authorized by QC
- .Participate in investigations, change implementation, deviation handling, audits, and corrective actions
- .Coordinate daily DSP operations
- .Support tech transfer projects and sample management activities
- .Manage equipment maintenance and related tasks
- .Perform additional responsibilities as assigned by the direct supervisor
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Requiremen
- t Diploma / Degree in Chemical/Biochemical Engineering, General Engineering, Biochemistry, or Electrical & Instrumentatio
- n.0 to 4 years of relevant experience in a bioprocess, pharmaceutical, or cell culture facility. Fresh graduates are highly welcome to appl
- y.Training Opportunity: Successful candidates will be eligible for our Overseas Training Program to accelerate technical competency and system onboardin
- g.Familiarity with MES and PCS systems (e.g., DeltaV, Unicorn) is an advantag
- e.Strong coordination and interpersonal skills; able to work cross-functionally and with multidisciplinary teams to achieve project goal
- s.Good understanding of GMP standards and relevant regulations (e.g., 21 CFR Part 11, EU Annex 11
- ).Team-oriented, proactive, and adaptable to dynamic timeline
- s.Overseas Training Program is availab
le