Senior CSV Engineer: Global IT & Compliance Leader

HOYA Surgical Optics; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

HOYA Surgical Optics seeks a Senior Engineer, Computer Systems Validation to lead CSV activities across GxP-regulated systems globally. You will oversee planning, testing, and validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

You will collaborate with Global IT, QA, Manufacturing, and Supply Chain to support ERP/MES/eQMS deployments and maintain audit readiness. A strong background in CSV and cross-functional leadership is required.

Qualifications

• Bachelor’s degree in engineering, Computer Science, Life Sciences, or related discipline.
• 3–5 years of experience in CSV within a GxP-regulated environment.
• Strong knowledge of cGMP, GDP, 21 CFR Part 11, EU Annex 11, ALCOA ++ and understanding of SDLC and GAMP 5 methodologies.

Responsibilities

• Manage the full CSV lifecycle (planning, design, testing, execution, reporting, and closure) for IT/software systems.
• Implement and execute CSV activities per SOPs and validation templates.
• Develop and execute CSV documentation (URS, FS, DQ, IQ/OQ/PQ).
• Perform risk assessments to determine validation scope and ensure compliance with guidelines.
• Handle validation deliverables for new global systems and upgrades, with periodic reviews.
• Collaborate on ERP, MES, eQMS, eVal projects and provide feedback to project teams.
• Act as CSV SME on frameworks and provide inputs during design and deployment.
• Coordinate with QA, IT, Operations for change control and release.
• Identify remediation-worthy discrepancies and escalate appropriately.

Skills

Documentation skills

Cross-functional collaboration

Validation project management

Enterprise-tools validation

Software architecture basics

Data integrity

Communication skills

Multi-tasking

Proactive CSV mindset

Quality-focused mindset

Education

Bachelor’s degree in Engineering

Bachelor’s degree in IT/CS/Life Sciences

Tools

ERP systems

MES

QMS

Document Management systems

Job description

HOYA Surgical Optics seeks a Senior Engineer, Computer Systems Validation to lead CSV activities across GxP-regulated systems globally. You will oversee planning, testing, and validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

You will collaborate with Global IT, QA, Manufacturing, and Supply Chain to support ERP/MES/eQMS deployments and maintain audit readiness. A strong background in CSV and cross-functional leadership is required.