CSV Validation Engineer - Life Sciences GxP

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

Job summary

ANTAES Asia Pte. Ltd. is seeking a CSV/GxP specialist to contribute to life science projects in Singapore.

You will oversee the computerized system lifecycle and ensure adherence to GXP standards and company policies. The role involves guiding data integrity, CSV planning, and 21 CFR Part 11 compliance. You will act as a key focal point for CSV topics such as deviations, change management, investigations, and CAPA closures, while reviewing qualification documents and protocols for software and

Qualifications

• 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.
• Working knowledge of CSV in OT/IT projects is a plus.
• Excellent written and spoken English communication.

Responsibilities

• Contribute to Life Science projects for Antaes Asia clients.
• Provide quality oversight in computerized system life cycle procedures and ensure GXP compliance.
• Guide on data integrity and CSV plans, 21 CFR Part 11 compliance.
• Act as SME on CSV topics including deviations, change management, investigations, CAPA.

Skills

Independent working

Team collaboration

Strong communication

English communication

Education

Diploma in Engineering/Life Science or equivalent

Tools

Emerson DeltaV system

Job description

ANTAES Asia Pte. Ltd. is seeking a CSV/GxP specialist to contribute to life science projects in Singapore.

You will oversee the computerized system lifecycle and ensure adherence to GXP standards and company policies. The role involves guiding data integrity, CSV planning, and 21 CFR Part 11 compliance. You will act as a key focal point for CSV topics such as deviations, change management, investigations, and CAPA closures, while reviewing qualification documents and protocols for software and