Lead API Process Engineer & Drug Substance SME

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

Job summary

AMTSOL is a leader in Life Sciences Manufacturing Technology solutions with a global footprint, including Singapore, Europe and the USA. We seek an experienced API/Drug Substance process engineer to provide technical leadership and design support for complex process systems.

The role involves translating requirements into specifications, ensuring CPP, CQA, GMP, and other regulatory needs are met, and guiding contractors through design and procurement activities.

Qualifications

• Strong pharmaceutical API / Drug Substance process engineering background.
• Knowledge of process equipment including reactors, chromatography, evaporation, freeze dryers, filter dryers and material transfer systems.

Responsibilities

• Provide technical leadership and engineering design support for API/Drug Substance process systems.
• Translate project requirements into Project Technical Requirements Specifications and engineering deliverables.
• Develop and review URS, ensuring CPP, CQA, CMA, GMP, GEP, SHE, and C&Q requirements are addressed.
• Review engineering contractor designs, drawings, calculations, specifications, and submissions.
• Define and align required design deliverables across Basic and Detailed Design stages.
• Participate in Design Assurance activities and maintain technical alignment throughout the project.
• Support technical package strategy, contractor/vendor prequalification, bid evaluation, and equipment selection.
• Participate in SHE and technical risk assessments and ensure mitigations are incorporated into the design.
• Identify value engineering opportunities while maintaining compliance, operability, cost and schedule objectives.
• Provide technical guidance to Work Package Owners and resolve engineering/construction queries.
• Support development of redundancy strategy, maintenance philosophy, sustainability requirements, and project planning.
• Act as the technical SME for assigned API process systems through design and project execution.

Skills

Pharmaceutical API process engineering

Technical leadership

Tools

Reactors

Chromatography

Evaporation

Freeze Dryers

Filter Dryers

Material transfer systems

Job description

AMTSOL is a leader in Life Sciences Manufacturing Technology solutions with a global footprint, including Singapore, Europe and the USA. We seek an experienced API/Drug Substance process engineer to provide technical leadership and design support for complex process systems.

The role involves translating requirements into specifications, ensuring CPP, CQA, GMP, and other regulatory needs are met, and guiding contractors through design and procurement activities.