Process Engineering SME / Lead – Drug Substance (mAbs)
On-siteSingapore, Singapore
Job Summary
Provide technical leadership for Drug Substance / mAbs process systems and translate requirements into engineering design deliverables. Develop and review URS, DQ, technical specifications, and equipment package documentation while supporting engineering design reviews and Design Assurance activities. Review vendor submissions to support technical equipment selection and participate in HAZOP, SWIFT, LOPA, and other process risk assessments. Drive value engineering and design-to-cost opportunities while ensuring GMP, GEP, SHE, and engineering standards are incorporated into the design. Act as the project SME for assigned process areas, working closely with engineering contractors, vendors, Work Package Owners, and C&Q teams to deliver compliant, practical, safe, and cost-effective solutions for major biopharmaceutical manufacturing projects.
Required Qualifications
- Strong pharmaceutical / biopharmaceutical process engineering experience
- Proven experience in mAbs / Drug Substance manufacturing
- Strong knowledge of upstream and/or downstream bioprocessing systems
- Experience with CAPEX, greenfield, brownfield, or major facility expansion projects
- Strong understanding of GMP engineering, URS, DQ, and C&Q requirements
- Experience working with engineering contractors and equipment vendors
- Strong technical leadership and stakeholder management skills
- Senior Process Engineer / Process SME / Drug Substance SME / Bioprocess Engineering Lead
Desired Qualifications
- Experience with bioreactors, chromatography, TFF, and buffer/media systems
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