CSV Validation Engineer – GXP, 21 CFR 11 Expert

ANTAES ASIA PTE. LTD.; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A leading consulting firm in Life Sciences located in Singapore is seeking a Validation Specialist to provide quality oversight and ensure compliance with GXP standards for various computerized systems. The ideal candidate will have a diploma in a relevant field and at least 1 year of hands-on experience with Emerson DeltaV systems. Strong communication skills and the ability to work independently are essential for success in this role.

Qualifications

• Minimum 1 year experience with Emerson DeltaV system - software coding review.
• Working experience and knowledge on CSV of start-ups and brownfield project experience in both Operation Technology / Information Technology system is a plus.

Responsibilities

• Contribute to Life Science projects for clients.
• Provide Quality oversight in computerized system life cycle procedure.
• Act as a Subject Matter Expert on CSV topics.
• Generate, review and execute protocols/test cases for validation programs.
• Ensure adherence to CSV master plans for GXP computer systems.

Skills

Hands-on experience in Validation life cycle of computer systems/GAMP 5

Excellent communication skills

Ability to work independently and in a team

Organizational skills

Education

Diploma in Engineering, Biotechnology, Life Science or equivalent

Tools

Emerson DeltaV system

Siemens PLC system

Job description

A leading consulting firm in Life Sciences located in Singapore is seeking a Validation Specialist to provide quality oversight and ensure compliance with GXP standards for various computerized systems. The ideal candidate will have a diploma in a relevant field and at least 1 year of hands-on experience with Emerson DeltaV systems. Strong communication skills and the ability to work independently are essential for success in this role.