A leader in Life Sciences Manufacturing Technology solutions, AMTSOLpartners with global pharmaceutical and biotechnology organizations to deliverAutomation, MES, CSV, CQV, and Digital Transformation solutions acrossSingapore, Europe, and the USA.

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 andengineering design support for a major pharmaceutical manufacturing project.

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

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 supportingChromatography
Associated Mechanical ProcessPackages

Key Responsibilities

Provide technical leadershipand engineering design support for API / Drug Substance process systems.
Translate project requirementsinto Project Technical Requirements Specifications and engineeringdeliverables.
Develop and review URS,ensuring CPP, CQA, CMA, GMP, GEP, SHE, and C&Q requirements areappropriately addressed.
Review engineering contractordesigns, drawings, calculations, specifications, and technical submissions.
Define and align requireddesign deliverables across Basic Design and Detailed Design stages.
Participate in DesignAssurance activities and maintain technical alignment throughout theproject.
Support technical packagestrategy, contractor/vendor prequalification, bid evaluation, and equipmentselection.
Participate in SHE andtechnical risk assessments and ensure appropriate mitigations are incorporatedinto the design.
Identify value engineeringopportunities while maintaining compliance, operability, cost, and scheduleobjectives.
Provide technical guidance toWork Package Owners and support resolution of engineering and constructionqueries.
Support development of redundancystrategy, maintenance philosophy, sustainability requirements, and projectplanning.
Act as the technical SME forassigned API process systems through design and project delivery.

Candidate Profile

Strong pharmaceutical API /Drug Substance process engineering background.
Good knowledge of processequipment such as reactors, chromatography, evaporation, freeze dryers, filterdryers, and material transfer systems.
Experience supportingpharmaceutical CAPEX / facility engineering projects.
Strong experience withengineering design reviews, technical specifications, URS, and equipmentpackages.
Experience working withengineering design contractors and equipment vendors.
Strong understanding of GMP,GEP, SHE, C&Q, and pharmaceutical engineering requirements.
Exposure to procurementstrategy, technical bid evaluation, and vendor selection.
Strong practicalproblem-solving, technical leadership, and stakeholder-management skills.

Preferred Background: