CSV Engineer - Life Cycle Validation for GxP Systems

XOT SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

XOT Solutions Pte. Ltd. in Singapore seeks a seasoned CSV Engineer to safeguard GxP computerized systems across their life cycle.

You will drive end-to-end validation for upgrades, data migrations, and retirements, while ensuring adherence to ALCOA+, GAMP 5 and global standards. Collaboration with IT, QA, and manufacturing is essential to maintain system integrity. The role emphasizes delivering validation plans, IQ/OQ/URS, and periodic reviews, plus risk assessments and data archiving

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
• 3–5 years of experience in Computerized System Validation within pharmaceutical/biotech/medical device industries.
• LCM expertise with post-implementation validation, upgrades, and change controls.
• Deep understanding of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, PIC/S, and Data Integrity guidelines.
• Experience validating enterprise/site-level systems (MES, DCS, LIMS, ERP, QMS, chromatographic data systems) is a plus.
• Strong analytical, writing, and multi-project management skills.

Responsibilities

• Lead end-to-end validation activities for GxP systems undergoing upgrades or data migrations.
• Develop, review, and execute validation deliverables (plans, URS, FDS, IQ/OQ, Traceability, Validation Summary Reports).
• Execute periodic reviews to ensure ongoing compliance.
• Plan decommissioning and data archiving per data integrity regs.
• Conduct Quality Risk Assessments for LCM changes to define testing scope.
• Ensure compliance with ALCOA+, GAMP 5, 21 CFR Part 11, and EU Annex 11.

Skills

Analytical thinking

Problem solving

Technical writing

Project management

Education

Bachelor’s degree in Engineering/CS/IS/Life Sciences

Tools

Syncade (MES)

Werum (MES)

DeltaV (DCS)

LIMS

SAP

QMS

Empower

Job description

XOT Solutions Pte. Ltd. in Singapore seeks a seasoned CSV Engineer to safeguard GxP computerized systems across their life cycle.

You will drive end-to-end validation for upgrades, data migrations, and retirements, while ensuring adherence to ALCOA+, GAMP 5 and global standards. Collaboration with IT, QA, and manufacturing is essential to maintain system integrity. The role emphasizes delivering validation plans, IQ/OQ/URS, and periodic reviews, plus risk assessments and data archiving