Senior Operations Engineer
Date Posted: February 6, 2026
Job Description
Seeking a Senior Operations Engineer for a major large-scale biologics project in Singapore. This role provides technical expertise in DeltaV/MES integration, batch record architecture, and recipe management. You will play a pivotal role from the commissioning phase through to Process Performance Qualification (PPQ), ensuring operational readiness in a high-growth GMP environment.
Key Responsibilities
Digital Manufacturing & Systems Architecture
Recipe & Batch Design: Design and optimize electronic batch records (eBR) and recipes for upstream (Media/Buffer) and complex downstream processes.
Automation Oversight: Provide unit-level DeltaV expertise, managing equipment running logic and procedural controls for critical unit operations.
MES Integration: Manage and troubleshoot batch record operations within the Manufacturing Execution System (MES) to ensure seamless data flow and compliance.
Project Lifecycle & Validation
Testing & FAT: Lead Software Factory Acceptance Testing (FAT), ensuring full integration of software, hardware, and skid-based systems.
Commissioning to PPQ: Drive the transition from system commissioning through to successful PPQ, collaborating with Quality and Automation teams.
Equipment Qualification: Oversee the GMP qualification of loose laboratory and floor equipment (e.g., analytical instruments, cold storage, and incubation systems).
Cross-Functional Coordination
- Act as the technical liaison between Operations, Engineering, and external vendors to ensure project milestones are met under strict GMP standards
Required Qualifications and Skills
Experience: 8+ years in Operations Engineering or Manufacturing Science within the Biologics/Pharma sector.
Technical Mastery: Deep hands-on knowledge of DeltaV (unit-level procedures) and MES (eBR design and troubleshooting).
Process Knowledge: Proven background in GMP manufacturing, specifically involving buffer preparation and purification technologies (Chromatography, UF/DF, Filtration).
Validation Core: Experience in FAT, software validation, and the qualification of ancillary GMP equipment.
Project Lifecycle: Previous experience supporting a project from late-stage construction/commissioning through to commercial readiness.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E
