About the Role
Anter Consulting is seeking experienced Senior MSAT Engineers to support one of our pharmaceutical vaccines manufacturing clients on a major brownfield expansion project in Singapore. The site is transitioning from SAT into active Commissioning and Qualification (C&Q), and this role sits within the Operational Readiness function - playing a critical part in ensuring process systems and equipment are technically ready for qualification, trial runs, PPQ and handover to manufacturing.
This is a hands-on technical role for someone who thrives in a fast-paced project environment and can hit the ground running during one of the most critical phases of a large-scale expansion.
Key Responsibilities
Trial Runs & PPQ
- Plan and execute engineering trial runs to assess process performance and equipment readiness ahead of formal qualification
- Lead and support Process Performance Qualification (PPQ) activities, ensuring process consistency and compliance with defined acceptance criteria
- Provide technical expertise during trial run execution - troubleshooting process deviations, interpreting data and driving corrective actions in real time
- Contribute to PPQ protocols, reports and technical summaries, ensuring documentation meets GMP and regulatory standards
- Support readiness reviews and stage-gate assessments ahead of PPQ execution
Commissioning & Qualification
- Support and execute SAT activities including system testing and functional verification
- Execute IQ, OQ and PQ protocols in line with site validation strategy and GMP requirements
- Provide hands-on MSAT support during system start-up, ensuring process equipment operates as intended prior to qualification
- Perform high-level troubleshooting during commissioning and testing phases, identifying and resolving process or equipment-related issues impacting operational readiness
- Support punch list development and closure from SAT through to operational handover
Operational Readiness & Handover
- Work closely with Operations, CQV, Engineering and Quality teams to ensure full alignment during execution and readiness reviews
- Identify risks to operational readiness and drive proactive mitigation with cross-functional teams
- Support smooth and compliant handover of qualified systems to manufacturing operations
- Contribute to technical reports, readiness assessments and lessons learned documentation post-qualification
Technical Scope
Hands-on support across process equipment and systems relevant to biologics and vaccines manufacturing, including:
- Ultrafiltration (UF/DF) systems
- Centrifuges
- Downstream processing equipment
Requirements
- Degree in Chemical Engineering, Biochemical Engineering, Biotechnology or a related discipline
- Minimum 5 years of experience in MSAT, process engineering or manufacturing support within pharmaceutical or biologics manufacturing
- Proven hands-on experience in trial run execution and PPQ - this is a core requirement of the role
- Experience supporting Commissioning and Qualification (IQ/OQ/PQ) activities in a GMP-regulated environment
- Hands-on experience with ultrafiltration systems and/or centrifuge operations preferred
- Strong troubleshooting and root cause analysis capability during start-up and commissioning phases
- Comfortable working in a brownfield project environment with multiple concurrent workstreams
- Strong communication and GMP documentation skills
