SME/Lead - Process Engineering Drug Substance

A leader in Life Sciences Manufacturing Technology solutions, AMTSOLpartners with global pharmaceutical and biotechnology organizations to deliverAutomation, MES, CSV, CQV, and Digital Transformation solutions acrossSingapore, Europe, and the USA.

Process Engineering SME / Lead - Drug Substance

Industry: Pharmaceutical / BiopharmaceuticalManufacturing

Role Overview

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

The role will act as the technical SME for mAbs DrugSubstance process systems, working closely with engineering teams,equipment vendors, Operations, C&Q, and project stakeholders to delivercompliant, 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 & TransferLines

. CIP Skids & Distribution Systems

. Drug Substance Process Utilities

Key Responsibilities

• Provide technical leadership for Drug Substance / mAbsprocess systems.
• Translate process requirements into engineering designdeliverables.
• Develop and review URS, DQ, technical specifications, andequipment package documentation.
• Support engineering design reviews and Design Assuranceactivities.
• Review vendor submissions and support technical equipmentselection.
• Participate in HAZOP, SWIFT, LOPA, and other process riskassessments.
• Drive value engineering and design-to-cost opportunitieswhile maintaining GMP, safety, and operability requirements.
• Work closely with engineering contractors, vendors, WorkPackage Owners, and C&Q teams.
• Ensure GMP, GEP, SHE, maintainability, and engineeringstandards are incorporated into the design.
• Act as the project SME for assigned Drug Substanceprocess areas.

Candidate Profile

• Strong pharmaceutical / biopharmaceutical processengineering experience.
• Proven experience in mAbs / Drug Substance manufacturing.
• Strong knowledge of upstream and/or downstreambioprocessing systems.
• Experience with bioreactors, chromatography, TFF, andbuffer/media systems preferred.
• Experience with CAPEX, greenfield, brownfield, or majorfacility expansion projects.
• Strong understanding of GMP engineering, URS, DQ, andC&Q requirements.
• Experience working with engineering contractors andequipment vendors.
• Strong technical leadership and stakeholder managementskills.

Preferred Background:

• Senior Process Engineer / Process SME / Drug Substance SME / BioprocessEngineering Lead.