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Process Engineering SME / Lead – API / Drug Substance
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Full-time
Posted 2d ago
~40 hrs/week
Responsibilities
Provide technical leadership and engineering design support for API and drug substance process systems throughout the project lifecycle. Ensure all process designs are compliant with GMP, SHE, and C&Q requirements while managing stakeholder expectations and project deliverables.
Requirements
Requires a strong background in pharmaceutical API process engineering and extensive experience with process equipment such as reactors and chromatography systems. Candidates must possess deep knowledge of engineering design reviews, technical specifications, and regulatory compliance standards.
Full 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.
Delivering innovation through technology for Life Science manufacturing!
Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2022
Headquarters
Singapore
LinkedIn followers
3,867
We are Delivering Innovation through Technology for Life Science Manufacturing. With focus on Pharma 4.0 and Digitalization, helping regulated manufacturers to increase speed to market and operating efficiency. Life Science Manufacturing Systems expert with end to end implementation and support capability of GMP Manufacturing systems and solutions for Automation, Manufacturing Execution Systems (MES), OT Networking and Digital Technologies.
Offices: Singapore, SG · Cork, IE · Pune, IN · Dover, DE, US
Delivering innovation through technology for Life Science manufacturing!
Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2022
Headquarters
Singapore
LinkedIn followers
3,867
We are Delivering Innovation through Technology for Life Science Manufacturing. With focus on Pharma 4.0 and Digitalization, helping regulated manufacturers to increase speed to market and operating efficiency. Life Science Manufacturing Systems expert with end to end implementation and support capability of GMP Manufacturing systems and solutions for Automation, Manufacturing Execution Systems (MES), OT Networking and Digital Technologies.
Offices: Singapore, SG · Cork, IE · Pune, IN · Dover, DE, US