Senior Engineer, Computer System Validation

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

• Accountable for our own capabilities and development.
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond self and are impact focused.
• Consider the needs, challenges, and objectives of every person they interact with
• Exhibit positive reinforcement to help others succeed.

Job Description

About the role

Job Title: Senior Engineer, Computer System Validation

Works closely with and have impact on: Global IT, Global QA, Manufacturing, Supply Chain.

Reports to: Computer System Validation Architect, Global

Function: Global IT

Role Overview

The Senior Engineer, Computer Systems Validation (CSV), as part of the Global IT team, is responsible for verification and validation activities for GxP-regulated computerized systems across Hoya Surgical Optics globally. This role ensures engineering compliance with relevant international regulations (including FDA 21 CFR Part 11, EUMDR, and MDSAP) alongside internal CSV and quality management standards. The individual will actively guide and collaborate with multi-functional project teams, system owners, and IT infrastructure specialists to support automated systems deployment and maintain regular system audit readiness.

Duties and 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.

Requirements

Experience

• 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 good understanding of system development lifecycle (SDLC) models and GAMP 5 methodologies.

Skills/Accreditations

• 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.

Academic Qualifications

• Bachelor’s degree in IT, Computer Science or Life Sciences disciplines.