Global CSV Engineer: GxP Validation & Compliance

HOYA MEDICAL SINGAPORE PTE. LTD.; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

HOYA MEDICAL SINGAPORE PTE. LTD. is seeking an Engineer, Computer Systems Validation (CSV) to join the Global IT team.

You will verify and validate GxP-regulated computerized systems worldwide, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and MDSAP, while supporting automated deployments. You will lead CSV activities across ERP, MES, and QMS projects, write URS/FS/DQ/IQ/OQ/PQ documents, perform risk assessments, and collaborate with QA, IT, operations, and system owners to maintain

Qualifications

• 3–5 years of CSV experience in GxP environments.
• Strong knowledge of cGMP, GDP, 21 CFR Part 11, EU Annex 11.
• SDLC methodologies and GAMP 5.

Responsibilities

• Manage the full CSV lifecycle (planning, design, testing, execution, reporting, and closure) for IT/software systems.
• Implement CSV activities per established policies, SOPs and templates.
• Develop and execute CSV documentation (URS, FS, DQ, IQ/OQ/PQ).
• Perform risk assessments to determine validation scope per GAMP 5 and 21 CFR Part 11.
• Collaborate with QA, IT, Operations, and system owners to ensure change management and audit readiness.

Skills

CSV lifecycle

GxP compliance

Documentation

Regulatory knowledge

SDLC understanding

Cross-functional collaboration

Education

Bachelor's degree in IT

Bachelor's degree in Computer Science

Bachelor's degree in Life Sciences

Tools

ERP

MES

QMS

Document Management

APIs

Job description

HOYA MEDICAL SINGAPORE PTE. LTD. is seeking an Engineer, Computer Systems Validation (CSV) to join the Global IT team.

You will verify and validate GxP-regulated computerized systems worldwide, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and MDSAP, while supporting automated deployments. You will lead CSV activities across ERP, MES, and QMS projects, write URS/FS/DQ/IQ/OQ/PQ documents, perform risk assessments, and collaborate with QA, IT, operations, and system owners to maintain