CSV Engineer

2 weeks ago

Singapore Coalesce Management Consulting Full time

Overview We are seeking a skilled CSV Engineer to provide quality oversight and validation support across the computerized system lifecycle within a biologics manufacturing environment. This role requires deep understanding of GxP standards, data integrity, and regulatory compliance, with hands-on experience in validating complex automation and IT systems. The ideal candidate will serve as a Subject Matter Expert (SME) in CSV, driving compliance and ensuring robust documentation and execution across multiple platforms. Responsibilities Provide quality oversight for computerized system lifecycle activities, ensuring alignment with GxP standards and internal policies. Act as SME for CSV topics including deviations, change controls, investigations, and CAPA management. Develop, review, and execute validation protocols and test cases for GxP systems (software, hardware, I/O loop verification). Review and approve qualification documents such as URS, SLIA/CLIA, SRA, DIRA/DSA, DQ, SIOQ/HIOQ, FAT, FATSR, and Traceability Matrix. Ensure adherence to CSV master plans and execution strategies for systems including DCS, PLC, BMS, MES, eBR, LIMS, EMS, Maximo, ERP, and network infrastructure. Collaborate with cross-functional teams (Engineering, Automation, Manufacturing, IT, QA) to ensure project milestones are met. Support CSV activities for both startup and brownfield projects across OT and IT domains. Perform other duties as assigned by the Line Manager. Qualifications Education: Degree or higher in Science or Engineering (or equivalent)Minimum 3 years of relevant experience in CSV within GMP-regulated environments Technical Skills: At least 1 year of experience reviewing Emerson DeltaV software coding Hands-on experience with the full validation lifecycle of computerized systems Familiarity with Siemens PLC systems is a plus Experience in startup and brownfield project CSV is advantageous Business Skills: Strong communication and cross-functional collaboration skills Proven ability to work independently and drive issue closure Solid understanding of pharmaceutical regulatory requirements (GMP)Team-oriented mindset with a focus on shared goals #J-18808-Ljbffr

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