Process Engineer

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