Computer System Validation (CSV) Engineer

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.

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