Computer System Validation (CSV) Specialist

Summary

The Computer System Validation (CSV) Specialist role is a global enterprise role. The Specialist manages the validation deliverables for computer systems to support product quality and compliance with internal/external standards, procedures, and regulations. The role requires applying specialized validation and regulatory knowledge mainly in the Medical Devices manufacturing area. The role’s responsibilities require a high level of independence, proactiveness, ownership, accountability, and communication (written/verbal) with diverse and global stakeholders and teams. The role also requires deep analysis, critical thinking, judgment calls, prioritization, continuous learning, and supporting/training others.

Detailed Description

Performs tasks such as, but not limited to, the following:

• Develops and executes validation plans, deliverables, and procedures that are consistent with the Celestica standards and the industry validation frameworks and principles (ex: GAMP 5, FDA CSA).
• Applies regulatory requirements and standards to systems, processes, and projects (ex: FDA Parts 11/820, EU GMP/MDR, ISO 9001/13485).
• Supports validation projects that use Software Development Life Cycle (SDLC) methodologies (ex: waterfall, agile). Creates, executes, and reviews validation deliverables within an SDLC process.
• Independently manages the CSV workstream deliverables of a project or change requests. Seeks support from management, other team members, or Subject Matter Experts (SMEs) as needed. Supports others in understanding and applying validation procedures.
• Analyzes a system’s intended use, business/technical processes, data flows, requirements, design, suppliers, and/or operations to identify GxP impacts and risks for projects and change requests. Recommends mitigations and approaches to handle GxP risks and impacts.
• Creates risk-based validation plans and reports for diverse business/technical systems, projects, and change requests. Creates and scales the rigor of validation deliverables based on the risk assessments.
• Analyzes and suggests improvements to operational change controls and configuration management procedures for GxP systems.
• Creates, maintains, and updates documents/records in accordance with regulatory standards and company procedures. Recommends records management approaches and improvements for GxP systems and projects.
• Supports the administration of the CSV documentation and records system with minimal supervision.
• Reviews validation deliverables created by others for suitability, accuracy, and completeness.
• Supports the CSV deliverables of periodic reviews and internal/external audits collaborating with cross-functional teams. Identifies and reports any deviations or non-conformance findings.
• Develops, reviews and/or revises policies, procedures, and guidelines for the CSV Program. Identifies gaps and improvement areas in the CSV Program and proposes solutions to address them.

Knowledge/Skills/Competencies

• ​​​​Strong understanding of the main industry validation frameworks, ex: GAMP 5, FDA CSA.
• Knowledge of the regulatory requirements and standards, ex: FDA Parts 11/820, EU GMP/MDR, ISO 9001/13485
• Knowledge and familiarity with the following  type of the systems is preferred, but not mandatory: Manufacturing Execution Systems (MES, ex: Siemens, Plex), Quality Management Systems (QMS, ex: EtQ), Enterprise Resource Planning (ERP, ex: SAP), Product Lifecycle Management Systems (PLM, ex: Enovia).
• Ability to continuously learn new technologies and business processes and operations willingly and proactively.
• Ability to work and think critically, independently, and proactively with minimal supervision.
• Ability to take end-to-end accountability and responsibility to drive assignments and projects to completion.
• Strong communication (written and verbal) skills in English.
• Ability to build relationships and communicate effectively with diverse and global business/technical stakeholders and teams.
• Strong project and team management and collaboration skills.

Typical Experience

• 3 to 5 years of CSV, QA, and/or Business/System Analysis experience.
• Preferred, but not mandatory, experience in the Medical Device manufacturing industry, other HealthTech regulated industries such as Pharmaceuticals, and/or the electronics manufacturing industry

Typical Education

• ​​Bachelor degree in computer science, engineering (computer, industrial, mechanical, electrical), business/information system management, or equivalent.
• Training in validation methodologies, technologies, and process control computer systems.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.