API Drug Substance Process Engineering Lead – SME

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

Job summary

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL) seeks an experienced Process Engineering SME/Lead for API/Drug Substance to provide technical leadership and engineering design support on a major pharmaceutical manufacturing project.

The role collaborates with design contractors, project teams, vendors, SHE, GMP, C&Q, ensuring designs are compliant, safe, and align with cost and schedule requirements. Seniority is preferred.

Qualifications

• Strong API/Drug Substance process engineering background.
• Knowledge of reactors, chromatography, evaporation, freeze dryers, filter dryers, and transfer systems.
• Experience supporting pharma CAPEX / facility projects.
• Experience with engineering design reviews, URS, and equipment packages.
• Experience working with engineering design contractors and equipment vendors.
• Solid GMP, GEP, SHE, C&Q understanding.
• Exposure to procurement strategies and vendor selection.
• Strong problem-solving, technical leadership, and stakeholder management.

Responsibilities

• Provide technical leadership and engineering design support for API / Drug Substance process systems.
• Translate project requirements into URS and deliverables.
• Review engineering contractor designs, drawings, calculations, specifications, and submissions.
• Define and align required design deliverables across Basic Design 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 support resolution of engineering and 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 delivery.

Skills

API process engineering

Pharma process design

Technical leadership

Stakeholder management

Job description

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL) seeks an experienced Process Engineering SME/Lead for API/Drug Substance to provide technical leadership and engineering design support on a major pharmaceutical manufacturing project.

The role collaborates with design contractors, project teams, vendors, SHE, GMP, C&Q, ensuring designs are compliant, safe, and align with cost and schedule requirements. Seniority is preferred.