Senior Computer System Validation (CSV) Engineer

Position Summary We are seeking a highly skilled and experienced Senior Computer System Validation (CSV) Engineer to lead the validation and qualification of automated computer systems within our pharmaceutical manufacturing operations. In this role, you will be responsible for ensuring that all automation IT/OT systems, manufacturing execution systems (MES), and control systems (DCS, PLC, SCADA) are validated across their entire life cycle in strict compliance with global regulatory requirements (e.g., HSA, FDA, EMA) and industry best practices (GAMP 5). Key Responsibilities Full Life Cycle Validation: Lead and manage the end-to-end computer system validation life cycle (Concept, Project, Operation, and Retirement) for manufacturing automation and IT/OT systems.

Validation Documentation: Author, review, and approve validation deliverables including Validation Master Plans (VMP), User Requirement Specifications (URS), Functional Specifications (FS), Hardware Design Specifications (HDS), Software Design Specifications (SDS), Risk Assessments, Traceability Matrices (RTM), IQ/OQ/PQ protocols, and Validation Summary Reports (VSR).

Regulatory Compliance: Ensure all automated systems comply with data integrity principles (ALCOA+), FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11, and relevant Singapore Health Sciences Authority (HSA) guidelines.

Risk Management: Conduct Quality Risk Assessments (QRA) for automated systems to determine validation strategies and test scaling based on GAMP 5 software categories.

System Testing & Execution: Oversee the execution of test protocols, investigate test failures, and manage validation discrepancies and deviations to resolution.

Vendor Management: Collaborate with automation vendors and system integrators. Review and leverage vendor documentation (FAT/SAT) to streamline internal qualification efforts.

Change Control & Maintenance: Assess the validation impact of system upgrades, patches, and configuration changes. Drive IT/OT change controls, CAPAs, and periodic system reviews to maintain a validated state.

Mentorship: Provide CSV guidance and subject matter expertise to cross-functional project teams (Engineering, Manufacturing, IT, and Quality).

Qualifications & Requirements Education: Bachelor’s degree in Engineering, Computer Science, Information Technology, Life Sciences, or a related discipline.

Experience: Minimum of 5–8 years of direct experience in Computer System Validation (CSV) within the Pharmaceutical, Biotechnology, or Medical Device industries.

Proven track record of validating automated process control systems (e.g., Siemens, Emerson DeltaV, Rockwell), SCADA, and MES platforms.

Technical Knowledge: Deep understanding of the System Development Life Cycle (SDLC) and the GAMP 5 V-Model.

Regulatory Expertise: Strong working knowledge of international pharmaceutical compliance standards (FDA 21 CFR Part 11, Annex 11, Data Integrity).

Skills: Excellent analytical and troubleshooting skills for complex automation architectures.

Strong technical writing and documentation skills.

Ability to manage multiple concurrent projects and work collaboratively across IT and OT domains. Please drop an email to careers@xotsolutions.com if you are keen with this position and not able to apply through the web portal.