Senior Operations Engineer
Date Posted: February 6, 2026
Job Description
The Senior Operations Engineer drives technical excellence and operational readiness for the GSK HPV project within a high-stakes biologics manufacturing environment. In this role, you provide the critical expertise needed to transition systems from commissioning through to Process Performance Qualification (PPQ). You take ownership of batch record design, recipe optimization, and the seamless integration of DeltaV and MES platforms to ensure that media, buffer, and purification processes run with maximum efficiency and regulatory compliance.
Key Responsibilities
- Design and Optimize Batch Records and recipes for media/buffer preparation and extraction processes, including centrifugation, chromatography, and sterile filtration.
- Master DeltaV and MES Operations by overseeing unit-level procedures and managing recipe logic to ensure smooth batch execution.
- Support Software FAT (Factory Acceptance Testing) to verify that software, hardware, and equipment systems integrate perfectly before site implementation.
- Lead Commissioning through PPQ activities, collaborating with Quality and Engineering to move systems into full operational status.
- Execute Loose Equipment Qualification for critical lab and production assets such as spectrophotometers, incubators, and cold storage units.
- Ensure GMP Compliance across all operational procedures, maintaining audit-readiness throughout the project lifecycle.
- Drive Stakeholder Coordination by providing technical leadership during project meetings and acting as the bridge between Automation, Operations, and Quality.
- Troubleshoot Complex Systems during the qualification and operational phases to mitigate delays and maintain project momentum.
Required Qualifications and Skills
- 8+ years of experience in operations engineering, specifically within a biologics manufacturing setting.
- Strong expertise in DeltaV (unit-level procedures/logic) and MES (batch record operation and troubleshooting).
- Demonstrate a deep understanding of extraction, purification, and media/buffer preparation systems.
- Hands-on experience in software FAT, system validation, and equipment qualification within a pharmaceutical environment.
- Bachelor’s degree in Engineering, Chemistry, Biotechnology, or a related technical field.
- Excel at working in cross-functional teams and managing relationships with internal stakeholders and external contractors.
- Apply structured problem-solving techniques to resolve technical issues during the commissioning and qualification phases.
- Familiar with Lean Six Sigma, brownfield project environments, and formal PPQ processes.
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