Job Description

Job Title: CSV (Computer System Validation) Engineer - Quality
Location: Tuas, Singapore
Industry: Life Sciences / Pharmaceutical Manufacturing
Role Overview:
We are looking for a Computer System Validation (CSV) Engineer with hands-on experience in validation documentation, test execution, and QA oversight support for regulated GxP systems. The ideal candidate will have strong grounding in validation lifecycle activities from URS through summary report and the ability to ensure compliance with internal quality standards and global regulatory expectations (GAMP 5, 21 CFR Part 11, Annex 11).
Key Responsibilities:

• Develop and execute test cases, test scripts, and validation protocols (IQ, OQ, PQ) in accordance with approved procedures.
• Prepare validation deliverables URS, Validation Plan, Traceability Matrix, Test Summary Reports, and Deviations.
• Support and coordinate validation testing activities under QA oversight.
• Ensure all documentation and test evidence meet data integrity (ALCOA+) and GxP compliance requirements.
• Participate in defect tracking, test incident resolution, and retest documentation.
• Collaborate with QA validation teams during review and approval of CSV deliverables.
• Contribute to change control, periodic review, and system revalidation activities.
• Maintain accurate audit-ready documentation for all validation activities.

Qualifications and Requirements:

• Bachelors degree in Engineering, Computer Science, Life Sciences, or related discipline.
• 36 years of experience in Computer System Validation within GxP-regulated environments.
• Proven experience in test case drafting, execution, and validation reporting.
• Exposure to validation of systems such as MES, LIMS, DCS/PLC, ERP, or other computerized systems.
• Sound understanding of GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Strong documentation and analytical skills.
• Ability to work collaboratively with QA, IT, and Engineering functions.

joinhands@amtsol.com

Skills Required