CSV Engineer (Life Sciences)

About the role

Antaes, a Swiss consulting firm founded in 2007, is hiring a CSV Engineer in Singapore for its Life Sciences practice. The role supports Antaes Asia clients on Life Science projects, acting as a quality oversight point for computerized systems and a subject matter expert on computer system validation.

Key responsibilities

• Contribute to Life Science projects for Antaes Asia clients.
• Provide quality oversight of computerized system lifecycle procedures and ensure compliance with GXP standards and company policies.
• Guide the establishment of systems for data integrity, CSV plan compliance and 21 CFR Part 11.
• Act as a focal point for deviations, change management, investigations, CAPA identification and closure.
• Generate, review and execute protocols and test cases for initial validation of GXP computer systems (software qualification, I/O loop verification, hardware qualification).
• Review and approve qualification documents such as URS, SLIA/CLIA, SRA, DIRA/DSA, DQ, SIOQ, HIOQ, FAT, FATSR and traceability matrices.
• Ensure adherence to CSV master and execution plans for DCS, PLC, BMS, MES, eBR, lab information systems, environmental monitoring systems and business systems such as Maximo, network and ERP systems.
• Support the promotion of Antaes services alongside client assistance.

Required profile

• Diploma in engineering, biotechnology, life sciences or equivalent.
• Minimum 1 year of experience reviewing software code on the Emerson DeltaV system.
• Hands-on experience in the validation lifecycle of computer systems / GAMP 5 is a must.
• Experience with CSV in start-ups and brownfield projects in OT and IT is a plus; Siemens PLC experience is also a plus.
• Excellent written and spoken English to liaise with English-speaking colleagues.
• Ability to work independently and in teams, with good organizational, oral and written communication skills.