CSV Validation Engineer

PSC Biotech® Corporation; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

PSC Biotech Corporation in Singapore seeks a skilled CSV engineer to oversee the computerized system life cycle and ensure GxP compliance. You will develop and maintain CSV plans aligned with 21 CFR Part 11 and author validation documentation.

The role requires 3+ years CSV experience and 1 year with Emerson DeltaV hardware/software, with responsibility for deviations, CAPA, and change controls, including document review and approval.

Qualifications

• 3+ years of CSV experience required.
• 1+ year experience with Emerson DeltaV hardware/software.

Responsibilities

• Oversee the computerized system life cycle and ensure GxP compliance.
• Develop and maintain CSV plans aligned with 21 CFR Part 11 requirements.

Skills

CSV experience

Emerson DeltaV

Job description

• Oversee the computerized system life cycle and ensure compliance with GxP standards and established procedures.
• Develop and maintain Computer System Validation (CSV) plans in alignment with 21 CFR Part 11 requirements.
• Manage deviations, change controls, investigations, and CAPA protocols.
• Author CSV protocols and related documentation.
• Review and approve documents before and after execution.

Job Qualifications / Minimum Requirements

• At least 3 years CSV exp and 1-year exp with Emerson DeltaV hardware/software system