mAbs Process Design SME — Engineering & DS Ops

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

Job summary

Advanced Manufacturing Tech Solutions in Singapore seeks a Drug Substance SME to support engineering design for mAbs processes, including equipment, CIP, buffers, and DS utilities. You will translate technical requirements into deliverables and collaborate with Exyte/Pharmadule Morimatsu to ensure GMP-aligned outcomes.

You will drive risk-based design decisions, review URSs, and support SHE/HAZOP, LOPA activities while coordinating with suppliers and site operations for compliant,

Responsibilities

• Work closely with the Designers (Exyte & Pharmadule Morimatsu) to develop the design, translating technical requirements into the agreed engineering deliverables.
• Coordinate with the site operations team and global support to align on critical technical areas and communicate with Exyte design team in a single, unified manner.
• Attend all necessary design discussions, provide technical direction on requirements, and drive a risk-based 'design to cost' approach within your areas of responsibility.
• Coach and support Exyte design team to develop URSs that are technically complete, correct, and suitable for CQ execution.
• Review and approve URSs within the technical area as Engineering SME Approver.
• Review and comment on engineering deliverables produced by Exyte & equipment suppliers.
• Attend supplier visits for critical equipment packages as required.
• Carry out periodic Design Assurance reviews (30/60/90%) to ensure alignment and identify value engineering opportunities.
• Provide technical support to SHE risk assessments (HAZOPs, SWIFT, LOPA) and ensure mitigations are included in the design.
• Collaborate with Work Package Owners to ensure compliant delivery of equipment packages; attend supplier visits as geography and carbon budget require.
• Participate in and make recommendations for procurement strategy for technical work packages, including pre-qualification and contractor selection.
• Review and comment on BD Design Deliverables within required review periods.
• Review and approve DQ protocols for critical equipment packages as they become available.
• Ensure SHE, sustainability targets, SME engagement and standards are incorporated into proposed solutions.
• Work with C&Q partners to ensure compliant delivery of equipment packages.

Job description

Advanced Manufacturing Tech Solutions in Singapore seeks a Drug Substance SME to support engineering design for mAbs processes, including equipment, CIP, buffers, and DS utilities. You will translate technical requirements into deliverables and collaborate with Exyte/Pharmadule Morimatsu to ensure GMP-aligned outcomes.

You will drive risk-based design decisions, review URSs, and support SHE/HAZOP, LOPA activities while coordinating with suppliers and site operations for compliant,