Process Engineering SME / Lead – Drug Substance (mAbs)

Advanced Manufacturing Tech Solutions; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Advanced Manufacturing Tech Solutions (AMTSOL) in Singapore seeks an experienced Process Engineering SME / Lead – Drug Substance to drive the design and delivery of a major biopharmaceutical manufacturing project.

You will serve as technical SME for mAbs Drug Substance process systems, collaborating with engineering teams, equipment vendors, Operations, C&Q, and project stakeholders to deliver compliant, safe, and cost-effective solutions.

Qualifications

• Strong pharmaceutical/biopharmaceutical process engineering experience.
• Proven experience in mAbs / Drug Substance manufacturing.
• Solid knowledge of upstream and/or downstream bioprocessing systems.
• Experience with bioreactors, chromatography, TFF, and buffer/media systems.
• Experience with CAPEX, greenfield, brownfield projects.
• Strong GMP engineering, URS, DQ, and C&Q knowledge.
• Experience with engineering contractors and equipment vendors.
• Strong technical leadership and stakeholder management.
• Background: Senior Process Engineer / Process SME / Drug Substance SME / Bioprocess Engineering Lead.

Responsibilities

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

Skills

Biopharmaceutical Process Engineering

MAbs Drug Substance

Upstream/Downstream Bioprocessing

Bioreactors

Chromatography

TFF

GMP URS DQ CQ Knowledge

Vendor Liaison

CAPEX/Greenfield/Brownfield

Leadership & Stakeholder Mgmt

Job description

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.