Process Engineering SME / Lead – API / Drug Substance

AMTSOL:

A leader in Life Sciences Manufacturing Technology solutions, AMTSOL partners with global pharmaceutical and biotechnology organizations to deliver Automation, MES, CSV, CQV, and Digital Transformation solutions across Singapore, Europe, and the USA

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

Must have:

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.