Senior DS Process Engineer (mAbs) & Equipment Design

Advanced Manufacturing Tech Solutions (AMTSOL); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AMTSOL is seeking a Drug Substance SME to provide engineering design support for mAbs processes, including bioreactors, chromatography and TFF skids, buffer and media prep systems, CIP skids, and logistics coordination.

You will work with Exyte and Pharmadule Morimatsu to translate requirements into deliverables, review URSs and supporting documents, and drive a value-engineered, cost-aware design. Occasional international supplier visits and SHE risk reviews are included.

Qualifications

• Experience translating technical requirements into the agreed engineering deliverables.
• Ability to develop URSs that satisfy CTQs, GMP, GEP and SHE requirements.
• Review URSs and engineering deliverables produced by design teams.

Responsibilities

• Work with Exyte & Pharmadule Morimatsu to develop design deliverables.
• Coordinate with site operations and global support for aligned technical positions.
• Provide technical direction in design discussions and drive design-to-cost decisions.
• Coach Exyte design teams to develop URSs that are technically complete and compliant.
• Review and approve URSs within the technical area as SME Approver.
• Review and comment on engineering deliverables from Exyte & equipment suppliers.
• Attend supplier visits for critical equipment packages.
• Conduct Design Assurance reviews (30/60/90%) to ensure alignment and identify value engineering opportunities.
• Support SHE risk assessments (HAZOPs, SWIFT, LOPA) and ensure mitigations are included.
• Collaborate with Work Package Owners to ensure compliant delivery of equipment packages.
• Participate in procurement strategy for technical work packages, including contractor pre-qualifications and scope.
• Review BD Design Deliverables within required review periods.
• Review and approve DQ protocols for critical equipment packages as available.
• Ensure SHE considerations, sustainability targets, SME engagement and standards are incorporated.
• Collaborate with C&Q partners to ensure compliant delivery of equipment packages.

Skills

Engineering design

URS development

GMP awareness

SHE compliance

Risk-based design

Job description

AMTSOL is seeking a Drug Substance SME to provide engineering design support for mAbs processes, including bioreactors, chromatography and TFF skids, buffer and media prep systems, CIP skids, and logistics coordination.

You will work with Exyte and Pharmadule Morimatsu to translate requirements into deliverables, review URSs and supporting documents, and drive a value-engineered, cost-aware design. Occasional international supplier visits and SHE risk reviews are included.