Process Engineering SME / Lead – Drug Substance

Advanced Manufacturing Tech Solutions; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

AMTSOL is seeking a Process Engineering SME / Lead for Drug Substance to drive design and delivery of pharmaceutical process systems. The role requires deep experience in Drug Substance operations with GMP-aligned engineering leadership and collaboration across vendors, C&Q teams, and internal stakeholders.

The candidate will develop URS, DQ and technical specs, review vendor submissions, and participate in HAZOP/LOPA and other risk assessments to ensure safe, compliant, and cost-effective

Qualifications

• Experience in drug substance manufacturing
• Strong understanding of GMP and process safety
• Ability to translate process requirements into design deliverables

Responsibilities

• 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.

Skills

Process Engineering

GMP Compliance

Pharmaceutical & Biopharma

Risk Assessment

Education

Bachelor's in Chemical/Pharma Engineering

Job description

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.

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

Key Responsibilities

• 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.