CSV Engineer

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

Job Description:

• Contribute to Life Science projects for Antaes Asia clients.
• Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures.
• Provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
• Act as one of the key focal points for CSV topics such as deviations, change management, investigations, CAPA identification and closure and as a Subject Matter Expert.
• Generate, review and execute protocols / test case for initial validation programs related to GXP Computer systems. -e.g. Qualifications protocols - Software qualification, Input/Output loop verification, hardware qualification.
• Review and approve qualification documentations like URS, SLIA (system level impact assessment)/ CLIA (component level impact assessment), SRA (System Risk Assessment), DIRA/ DSA (Data security, audit trail review), DQ, SIOQ, HIOQ, FAT, FATSR, Traceability Matrix etc.
• Ensure adherence to CSV master plans and execution plans for GXP computer systems like DCS, PLC, BMS, MES, eBR, Lab Information systems, Environmental monitoring systems and other Business IT systems like Maximo, Network and ERP systems that are part of the GMP envelope.
• Any other tasks assigned.
• Contribute to the promotion of Antaes services on top of assistance provided to clients.

Job Requirements:

• Diploma in Engineering, Biotechnology, Life Science or equivalent.
• Minimum 1 year experience with Emerson DeltaV system - software coding review.
• Hands-on experience in Validation life cycle of computer systems/ GAMP 5 is a must.
• Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus.
• Experience in Siemens PLC system is a plus.
• Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills.
• Excellent communication skills, both written and verbal, in English - to coordinate and liase with English speaking counterparts.