Engineer, Computer System Validation

The 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. Authority • N/A 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.