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.