QA CSV Engineer

The CSV Engineer (Computer System Validation Engineer) is responsible for validating and maintaining computerized systems to meet regulatory requirements and industry best practices.

Responsibilities:

• Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for laboratory analytical instruments (e.g Cell Viability Analysers etc.)
• Create and execute test protocols designed to verify compliance of the system with data integrity principles and regulatory requirements.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
• Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
• Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
• Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.

Requirements:

• Bachelor's degree in Engineering, Science, Computer Science or a related field.
• Experience working in a similarly large biologics company, preferably within a Validation, Analytical or Quality Assurance role.
• Knowledge of Validation principles and processes.
• Basic understanding of the regulatory requirements associated with data integrity and validation including: ALCOA+, 21CFR Pt 11 and EU Annex 11.