CSV Engineer

Job Description:
The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. This role ensures the systems are compliant, reliable, and fit for intended use, supporting quality and regulatory requirements across the organization.
Responsibilities:

• Develop and execute Computer System Validation (CSV) deliverables including Validation Plans, User Requirements, Risk Assessments, Test Protocols (IQ, OQ, PQ), and Validation Reports.
• Review and assess computerized systems for compliance with FDA, ISO, and GAMP 5 guidelines.
• Collaborate with cross-functional teams including Quality, IT, Manufacturing, and Engineering to validate systems such as MES, ERP, LIMS, PLC/SCADA, and eQMS.
• Participate in software implementation projects by defining validation requirements early in the lifecycle.
• Maintain validation documentation in compliance with internal procedures and external regulatory requirements.
• Lead or support periodic reviews and re-validation of legacy systems.
• Investigate and document deviations and non-conformances; implement CAPA when necessary.
• Assist in audits (internal and external) related to CSV processes.
• Support training initiatives related to CSV and regulatory compliance.

Requirements:

• Bachelor's degree in engineering, Computer Science, Life Sciences, or a related technical discipline.
• 3+ years of experience in CSV within a regulated industry, preferably medical devices or pharmaceuticals.
• Strong knowledge of regulatory requirements (21 CFR Part 11, ISO 13485, GAMP 5, EU Annex 11).
• Experience validating systems such as ERP, MES, LIMS, SCADA, or eQMS.
• Strong documentation and technical writing skills.
• Detail-oriented with excellent problem-solving and analytical skills.
• Ability to work independently and manage multiple projects.
• Strong communication and interpersonal skills.