Process Engineering SME / Lead Drug Substance

Advanced Manufacturing Tech Solutions (AMTSOL)
www.amtsol.com

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.

• Process Engineering SME / Lead – Drug Substance
• Industry: Pharmaceutical / Biopharmaceutical Manufacturing

Role Overview

AMTSOL is seeking an experienced Process Engineering SME / Lead – Drug Substance to support the engineering design and technical delivery of a major biopharmaceutical manufacturing project.

The role will act as the technical SME for mAbs Drug Substance process systems, working closely with engineering teams, equipment vendors, Operations, C&Q, and project stakeholders to deliver compliant, practical, safe, and cost-effective process solutions.

Key Process Areas

• Single-Use Bioreactors
• Chromatography Systems
• Tangential Flow Filtration (TFF)
• Buffer & Media Preparation
• Process Vessels, Filling Stations & Transfer Lines
• CIP Skids & Distribution Systems
• Drug Substance Process Utilities

Key Responsibilities

• Provide technical leadership for Drug Substance / mAbs process systems.
• Translate process requirements into engineering design deliverables.
• Develop and review URS, DQ, technical specifications, and equipment package documentation.
• Support engineering design reviews and Design Assurance activities.
• Review vendor submissions and support technical equipment selection.
• Participate in HAZOP, SWIFT, LOPA, and other process risk assessments.
• Drive value engineering and design-to-cost opportunities while maintaining GMP, safety, and operability requirements.
• Work closely with engineering contractors, vendors, Work Package Owners, and C&Q teams.
• Ensure GMP, GEP, SHE, maintainability, and engineering standards are incorporated into the design.
• Act as the project SME for assigned Drug Substance process areas.

Candidate Profile

• Strong pharmaceutical / biopharmaceutical process engineering experience.
• Proven experience in mAbs / Drug Substance manufacturing.
• Strong knowledge of upstream and/or downstream bioprocessing systems.
• Experience with bioreactors, chromatography, TFF, and buffer/media systems preferred.
• Experience with CAPEX, greenfield, brownfield, or major facility expansion projects.
• Strong understanding of GMP engineering, URS, DQ, and C&Q requirements.
• Experience working with engineering contractors and equipment vendors.
• Strong technical leadership and stakeholder management skills.

• Preferred Background:
  Senior Process Engineer / Process SME / Drug Substance SME / Bioprocess Engineering Lead.