CSV Administrator – GMP Regulated Systems

About the role

Our client is looking for a CSV Administrator to manage and support computerised systems in a GMP‑regulated pharmaceutical manufacturing environment. The role focuses on user access administration, system compliance and supporting validation activities across multiple GxP platforms.

Key responsibilities

• Manage and maintain user access for all GxP systems, ensuring timely provisioning and de‑provisioning.
• Administer regulated systems such as MES, LIMS and other site platforms.
• Ensure all system administration activities comply with GMP, data integrity and regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11).
• Support CSV activities, including documentation updates, periodic reviews and change control.
• Maintain audit trails and assist with inspection readiness.
• Collaborate with IT, QA and system owners to ensure smooth operation and compliance.
• Participate in system lifecycle tasks such as upgrades, patches and enhancements.
• Provide end‑user support and troubleshoot system‑related issues.
• Contribute to SOP development and ongoing compliance documentation.
• Engage in data integrity initiatives and continuous improvement projects.

Required profile

• Degree in IT, Computer Science, Engineering, Life Sciences or a related discipline.
• Experience working in a GMP‑regulated pharmaceutical environment.
• Proven experience in system administration or IT support roles.
• Hands‑on experience managing user access and system administration activities.
• Exposure to CSV (Computer System Validation) activities.
• Strong understanding of regulatory requirements for computerised systems and data integrity.
• Ability to work independently and manage multiple priorities in a fast‑paced setting.

Required skills

• System administration
• User access management
• CSV documentation and change control
• MES
• LIMS
• GxP platform support
• Data integrity practices
• Regulatory compliance (FDA 21 CFR Part 11, EU Annex 11)