Quality Assurance Engineer

3 days ago


Singapore UNISON CONSULTING PTE. LTD. Full time

We are looking for Process Engineers (4–6 years) with strong manufacturing operations and process knowledge to support Commissioning & Qualification (C&Q) activities. Candidates with working knowledge of DeltaV — including recipes, phases, and batch execution — will be preferred. The role involves collaborating with manufacturing, QA, and automation teams to ensure equipment and process systems are qualified and ready for GMP production. Key Responsibilities Support C&Q execution for process equipment, utilities, and manufacturing systems. Review and execute qualification protocols (IQ, OQ, PQ) and support FAT/SAT activities. Provide process and operational input during commissioning and troubleshooting. Support DeltaV-related activities (recipes, phases, batch execution understanding). Develop/review C&Q documentation (URS, risk assessments, protocols, reports). Ensure adherence to GMP, regulatory, and data integrity requirements. Collaborate with operations, QA, and automation teams to meet project deliverables. Qualifications and Requirements Bachelor’s degree in chemical / Biochemical / Process / Mechanical Engineering or related field. 4–6 years’ experience in pharmaceutical/biotech manufacturing or operations, with exposure to C&Q. Strong process knowledge of pharmaceutical manufacturing. Working knowledge of DeltaV – recipes, batch execution, troubleshooting. Hands-on experience with C&Q documentation and execution (IQ, OQ, PQ). Good knowledge of cGMP, FDA/EMA guidelines, and industry practices. #J-18808-Ljbffr



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