CSV Engineer: Global GxP Systems Validation

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

Job summary

HOYA MEDICAL SINGAPORE PTE. LTD. seeks an Engineer, Computer Systems Validation to join the Global IT team and drive CSV for GxP-regulated systems across Hoya Surgical Optics.

You will align with global regulations and internal quality standards while collaborating with project teams, system owners and IT infrastructure specialists. The role emphasizes risk-based validation, creation of URS/FS/DQ/IQ/OQ/PQ, and audit readiness, supporting ERP, MES and QMS deployments and ensuring data integrity

Qualifications

• Excellent documentation, analytical, and problem-solving skills.
• Ability to work cross-functionally and manage multiple validation projects simultaneously.
• Exposure to validating enterprise-scale operational tools, such as ERP, MES, QMS, enterprise Document Management systems, or related regulated industrial applications.
• Foundational understanding of core software architecture environments, interface protocols, APIs, modern Agile project execution sprints, or common technical data workflows.
• Meticulous attention to detail with an unyielding commitment to data integrity and technical precision.
• Excellent interpersonal, verbal, and written communication skills to articulate validation concepts clearly across multicultural engineering, IT, and quality control teams.
• Strong dynamic problem-solving and multitasking capability to manage multiple cross-functional tracking deadlines simultaneously inside fast-paced schedules.
• Demonstrate a proactive, self-driven, and flexible approach to CSV, with the ability to adapt to evolving business needs and apply risk-based, assurance-focused thinking.
• Take on additional projects or stretch assignments as required, with a strong motivation to deliver quality outcomes and add value to the organization.

Responsibilities

• Manage the full CSV lifecycle (planning, design, testing, execution, reporting, and closure) for IT/software systems at HSO while applying risk-based validation approaches in line with industry standards.
• Implement and execute Computer Systems Validation (CSV) activities strictly in accordance with established organizational policies, SOPs, and pre-defined validation templates.
• Develop and execute CSV documentation including User Requirement Specifications (URS), Functional Specifications (FS), Design Qualification (DQ), Testing and Qualification (IQ, OQ, PQ).
• Able to perform risk assessments to determine validation scope and ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and other relevant guidelines.
• Handle validation deliverables for new global system implementations, infrastructure upgrades, operational optimization, and required periodic reviews of existing automated GxP platforms.
• Involve actively as a CSV engineer for global implementation projects such as ERP, MES, eQMS, eVal projects and review/approve/provide valuable feedback to project teams and external vendors.
• Function actively as an engineering Subject Matter Expert (SME) on distinct software CSV frameworks and provide technical compliance inputs proactively during systems initial design, custom configuration, deployment setups, and routine functional phase rollouts.
• Collaborate with internal QA, IT, Operations teams as well as system owners to ensure proper change management, deviation handling, and system release.
• Identify prospective processing errors or localized compliance gaps, escalating discrepancies through formal remediation workflows for structured resolution.

Job description

HOYA MEDICAL SINGAPORE PTE. LTD. seeks an Engineer, Computer Systems Validation to join the Global IT team and drive CSV for GxP-regulated systems across Hoya Surgical Optics.

You will align with global regulations and internal quality standards while collaborating with project teams, system owners and IT infrastructure specialists. The role emphasizes risk-based validation, creation of URS/FS/DQ/IQ/OQ/PQ, and audit readiness, supporting ERP, MES and QMS deployments and ensuring data integrity