Computer System Validation (CSV) Engineer

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

Role Overview

We are seeking a highly skilled Computer System Validation (CSV) Engineer to support our pharmaceutical operations in Singapore. In this role, you will be the subject matter expert responsible for ensuring that all GxP computerized systems remain in a validated state throughout their operational life. Your primary focus will be on Life Cycle Management (LCM) projects, including system upgrades, data migrations, continuous improvements, and system retirements.

You will work closely with Automation, Quality Assurance, IT, Engineering, and Manufacturing teams to ensure that all system modifications comply with internal procedures, local HSA regulations, and global regulatory standards (FDA 21 CFR Part 11, EU Annex 11, and GAMP 5).

Key Responsibilities

Life Cycle Management (LCM) Validation

• Lead the end-to-end validation activities for existing GxP computerized systems undergoing upgrades, patches, or data migrations.
• Develop, review, and execute validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, IQ/OQ protocols, Traceability Matrices, and Validation Summary Reports.
• Execute and manage Periodic Reviews for critical computerized systems to ensure ongoing compliance.
• Plan and execute system decommissioning and data archiving strategies in accordance with data integrity regulations.

Compliance & Risk Management

• Conduct Quality Risk Assessments (QRA) and System Risk Assessments for LCM changes to determine the appropriate scope of validation testing.
• Ensure all computerized systems comply with Data Integrity (ALCOA+) principles, GAMP 5 guidelines, 21 CFR Part 11, and EU Annex 11.

Cross-Functional Collaboration

• Partner with System Owners, IT, and external vendors to evaluate the compliance impact of proposed system changes (Change Control management).
• Provide guidance and training to operational teams on good documentation practices (GDP) and CSV standards.

Qualifications & Requirements

• Education: Bachelor’s Degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
• Experience: Minimum of 3–5 years of working experience in Computerized System Validation within the pharmaceutical, biotechnology, or medical device industry.
• LCM Expertise: Proven track record of handling post-implementation validation, system upgrades, and change controls for manufacturing or laboratory systems.
• Regulatory Knowledge: Deep understanding of GAMP 5 methodologies, FDA 21 CFR Part 11, EU Annex 11, PIC/S, and Data Integrity guidelines.
• Technical Familiarity: Experience validating enterprise or site-level systems such as MES (e.g., Syncade, Werum), DCS (e.g., DeltaV), LIMS, ERP (SAP), QMS, or chromatography data systems (e.g., Empower) will be a plus.
• Skills: Strong analytical and problem-solving abilities, excellent technical writing skills, and the capacity to manage multiple LCM projects simultaneously in a fast-paced environment.