CSV Engineer: Life Sciences Validation & Compliance

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

ANTAES ASIA PTE. LTD. is seeking a qualified professional to contribute to Life Science projects, providing quality oversight in CSV and ensuring GXP compliance. The role involves facilitating data integrity, guiding systems, and serving as a SME on CSV topics such as deviations, investigations, and CAPA.

The position requires hands-on validation of computer systems, qualification protocols, and review of critical documentation like URS, DQ, and FAT, with English communication across teams.

Qualifications

• Diploma in Engineering, Biotechnology or Life Science or equivalent.
• Hands-on validation life cycle experience for computer systems/CSV.
• Experience with start-ups and brownfield projects in OT/IT is a plus.
• English communication skills, able to coordinate with counterparts.

Responsibilities

• Contribute to Life Science projects for Antaes Asia clients.
• Provide quality oversight in CSV and ensure GXP compliance.
• Support data integrity and adherence to CSV plans and 21 CFR Part 11.
• Act as focal point for CSV topics like deviations, changes, investigations.
• Generate, review and execute qualification protocols and test cases.
• Review qualification documents such as URS, DQ, FAT, SRA, and traceability.

Skills

Data integrity

CSV validation

GAMP 5 compliance

Validation lifecycle

Software qualification

Problem solving

Education

Diploma in Engineering, Biotechnology or Life Science

Tools

Emerson DeltaV

Siemens PLC

Job description

ANTAES ASIA PTE. LTD. is seeking a qualified professional to contribute to Life Science projects, providing quality oversight in CSV and ensuring GXP compliance. The role involves facilitating data integrity, guiding systems, and serving as a SME on CSV topics such as deviations, investigations, and CAPA.

The position requires hands-on validation of computer systems, qualification protocols, and review of critical documentation like URS, DQ, and FAT, with English communication across teams.