- Singapore
Kerja Sepenuh Masa, Process Engineering SME - Lead – Drug Substance di Advanced Manufacturing Tech Solutions - Maukerja
Process Engineering SME - Lead – Drug Substance
Advanced Manufacturing Tech Solutions
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
AMTSOL:
A Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.
Role: Process Engineering SME / Lead – Drug Substance
Experience - 5 yrs & above in pharmaceutical / biopharmaceutical process
Key Process Areas
A Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.
Role: Process Engineering SME / Lead – Drug Substance
Experience - 5 yrs & above in pharmaceutical / biopharmaceutical process
Key Process Areas
- Single-Use Bioreactors
- Chromatography Systems
- Tangential Flow Filtration (TFF)
- Buffer & Media Preparation
- Process Vessels, Filling Stations & Transfer Lines
- CIP Skids & Distribution Systems
- Drug Substance Process Utilities
- Provide technical leadership for Drug Substance / mAbs process systems.
- Translate process requirements into engineering design deliverables.
- Develop and review URS, DQ, technical specifications, and equipment package documentation.
- Support engineering design reviews and Design Assurance activities.
- Review vendor submissions and support technical equipment selection.
- Participate in HAZOP, SWIFT, LOPA, and other process risk assessments.
- Drive value engineering and design-to-cost opportunities while maintaining GMP, safety, and operability requirements.
- Work closely with engineering contractors, vendors, Work Package Owners, and C&Q teams.
- Ensure GMP, GEP, SHE, maintainability, and engineering standards are incorporated into the design.
- Act as the project SME for assigned Drug Substance process areas.
Peringatan Penting
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