We are seeking a CSV (Computer System Validation) Specialist to join our Quality and Compliance team within a regulated, fast-paced medical industry environment. The ideal candidate will support the validation of computer systems, ensuring they meet internal procedures and external regulatory standards. This role is key to maintaining data integrity, system security, and audit readiness across all validated systems on site.

Key Responsibilities:

• Maintain and regularly update the site Computer System Inventory (CSI) list.
• Serve as author and/or reviewer for validation deliverables, including:
• Validation Plans
• User Requirements Specifications (URS)
• Validation Protocols (IQ/OQ/PQ)
• Test Plans
• Summary Reports
• Change Controls
• Ensure that all validation documentation complies with local and corporate quality policies and applicable regulations (e.g., GxP, FDA, EMA).
• Conduct and/or review Computer System Validation (CSV) protocols to ensure consistency, accuracy, and compliance.
• Evaluate and validate systems considering data integrity, user access, security, and business impact.
• Participate in CAPA management, working with cross-functional teams to investigate and resolve quality issues.
• Support audit readiness efforts by ensuring documentation and practices are compliant with regulatory expectations.

Basic Requirements:

• Basic knowledge of Computer System Validation (CSV) processes in a regulated environment.
• Understanding of Change Control and CAPA (Corrective and Preventive Actions).
• 2 years on similar roles
• Familiarity with quality management systems and regulatory requirements in the life sciences or medical industry.

Preferred Qualifications:

• Exposure to global organizations, international projects, or working with diverse, cross-functional teams.
• Experience in the medical device, pharmaceutical, or biotech industries is a strong plus.
• Working knowledge of GAMP 5, 21 CFR Part 11, and Annex 11 is highly desirable.