Process Engineering SME / Lead – API / Drug Substance

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

Process Engineering SME / Lead - API / Drug Substance

• Industry: Pharmaceutical / API Manufacturing


• Function: Process Engineering

Role Overview

AMTSOL is seeking an experienced Process Engineering SME / Lead - API / Drug Substance to provide technical leadership and engineering design support for a major pharmaceutical manufacturing project.

The role will work closely with engineering design contractors, project teams, equipment vendors, SHE, GMP, C&Q, and other stakeholders to ensure process designs are technically compliant, practical, safe, maintainable, and aligned with project cost and schedule requirements.

Key Process Areas

• The scope may include:


• Chemical Warehouse


• Material Transfer & Logistics


• Purification Systems - Chromatography & Evaporation


• Freeze Dryers


• Process Reactors


• Filter Dryers


• Solvent Break Tanks supporting Chromatography


• Associated Mechanical Process Packages

Key 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 appropriately addressed.


• Review engineering contractor designs, drawings, calculations, specifications, and technical 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 appropriate 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.

Candidate Profile

• Strong pharmaceutical API / Drug Substance process engineering background.


• Good knowledge of process equipment such as reactors, chromatography, evaporation, freeze dryers, filter dryers, and material transfer systems.


• Experience supporting pharmaceutical CAPEX / facility engineering projects.


• Strong experience with engineering design reviews, technical specifications, URS, and equipment packages.


• Experience working with engineering design contractors and equipment vendors.


• Strong understanding of GMP, GEP, SHE, C&Q, and pharmaceutical engineering requirements.


• Exposure to procurement strategy, technical bid evaluation, and vendor selection.


• Strong practical problem-solving, technical leadership, and stakeholder-management skills.
  Preferred Background:


• Senior Process Engineer / Process SME / API SME / Drug Substance SME / Process Engineering Lead.