Information Technology Support Specialist

Job title - IT Systems Support & Validation Specialist

Location- Burton Upon Trent, England, United Kingdom(Onsite)

Employement type- Full-time

Summary of Job Purpose:

To manage first-line support providers and provide second-line IT support for GxP and nonGxP systems while supporting system development, continuous improvements, computer system validation (CSV), and IT projects in a regulated pharmaceutical environment. The role ensures that systems are implemented, maintained, and operated in accordance with regulatory expectations, internal procedures, and data integrity principles. The position provides oversight of system lifecycle management including system configuration, change control, validation activities, and coordination with external IT service providers. The role also supports the continuous improvement of business systems to ensure they remain efficient, compliant, and aligned with organisational growth. The role supports day-to-day system operations and contributes to continuous improvement of IT systems and processes.

Key Responsibilities:

Coordination, Management & Oversight • Management and coordination of external 1 st line IT support providers (hardware, software, systems, and access issues) • Provide 2nd line IT support (support system testing and improvements, assisting with technical problem solving, and escalated issues resolution) • Troubleshoot and resolve basic technical issues • Coordinate device provisioning, onboarding and offboarding activities, and asset management with the IT provider • Manage IT support tickets with service providers, documentation, and user guides • Maintain oversight of the organisation’s digital systems to ensure they operate in accordance with internal procedures, regulatory expectations, and good practice • Support compliance with internal IT and quality procedures • Support periodic system reviews and audit readiness • Ensure compliance with data integrity principles (ALCOA+) • Monitor service performance and ensure service providers meet agreed service levels and contractual obligations.

Skills and competency required for the role:

GxP awareness and data integrity principles (ALCOA+) • Experience supporting or administering enterprise or SaaS platforms such as CRM, QMS, or ERP systems • Strong understanding of computerised systems in a regulated environment (GAMP 5) • Proven 1 st and 2 nd line understanding and experience (tickets, troubleshooting, escalations, onboarding / offboarding, asset/admin) • Experience with CSV (executing test scripts, IQ/OQ/PQ or UAT/Functional, documenting evidence, URS/FS) • Familiarity with Microsoft 365 and enterprise applications • Understanding of databases, interfaces, system integrations and CRM / ERP systems such as Salesforce • Interest in systems development, automation, or low-code tools is desirable • Basic knowledge of networking concepts (LAN, VPN, user access) • Strong problem solving and analytical skills • Ability to communicate effectively with both technical and non-technical stakeholders • Excellent organisational skills with strong attention to detail • Ability to work independently while collaborating across multiple departments

System development and CSV

Assist and manage the development, configuration, and enhancements of internal systems such as Salesforce • Manage system upgrades and help gather user / business requirements and feedback for system improvements. Perform and coordinate testing activities of system patches, updates and development activities to support CSV (e.g. functional testing, UAT support) • Support the validation lifecycle of systems that impact regulated activities in accordance with GAMP 5 principles • Manage the preparation, execution and maintenance of CSV documentation (Change Control, URS, FS, risk assessments, test scripts, IQ/OQ/PQ where applicable) • Assist the Director of Operations with IT project activities including documentation, status updates and coordinate with internal teams and external service providers where required • Assist with training and go-live activities for new systems.