Process Engineering SME / Lead API / Drug Substance

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.