About the Role
Anter Consulting is looking for a Process Engineer to support one of our pharmaceutical API manufacturing clients in Singapore. This is a process-focused, hands-on role centred on changeover activities, cleaning validation execution, process control and GMP documentation. The role is well-suited to a candidate early in their career who is looking to build deep expertise in API manufacturing operations within a regulated GMP environment.
Key Responsibilities
Changeover & Cleaning
- Execute and support product changeover activities between manufacturing campaigns in line with approved procedures and GMP requirements
- Perform and support cleaning validation activities including execution of cleaning protocols, sampling, swab and rinse testing coordination
- Ensure equipment is cleaned, inspected and released within defined timelines to maintain production schedule
- Identify and escalate any cleaning failures, deviations or out-of-specification results during changeover
Process Control & Operations Support
- Monitor and control process parameters during manufacturing operations, ensuring alignment with approved batch records and process specifications
- Support continuous improvement initiatives related to cleaning efficiency, changeover time reduction and process robustness
- Assist in troubleshooting process and equipment issues during manufacturing campaigns
- Liaise with QC laboratory for in-process sampling and testing coordination
Change Control & Documentation
- Prepare, review and support change control activities related to cleaning procedures, process parameters and equipment changes
- Execute and complete batch manufacturing records (BMRs) and logbooks accurately and in real time
- Draft and review SOPs, cleaning validation protocols, reports and other GMP documentation
- Support deviation investigations related to cleaning and changeover activities - contributing to root cause analysis and CAPA implementation
- Maintain accurate and audit-ready documentation at all times in line with GMP data integrity requirements
Requirements
- Degree in Chemical Engineering, Chemistry, Pharmaceutical Science or a related discipline
- Minimum 1 year of experience in a pharmaceutical or API manufacturing environment
- Basic understanding of GMP principles, cleaning validation and change control processes
- Hands-on experience or exposure to batch record execution and GMP documentation
- Attention to detail and a disciplined approach to following procedures and documentation standards
