At Target Healthcare, we are pioneers, innovators, and lifesavers, committed to making a significant difference in the world of healthcare. Our vision is to facilitate a world where every patient as has access to the medication they need.
Today, we are one of the fasting growing healthcare companies in the UK, employing over 500 diverse professionals including pharmacists, skilled technicians, HR, IT, Procurement, warehouse and customer service staff.
Our IT department is at the heart of everything we do – keeping our systems running, our data secure and our teams connected. We’re looking for a dedicated Computer Systems Validation Specialist to join our dynamic team.
If you’re ready to make an impact in a fast-paced, collaborative environment, we want to hear from you.
As a skilled Computerised Systems Validation (CSV) Specialist, you will be required to support the validation and lifecycle management of both custom-built and commercial off-the-shelf (COTS) systems used throughout our pharmaceutical operations. This role is essential to ensuring compliance with GAMP 5 guidelines and global regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), while also supporting a company-wide risk stratification initiative for all GxP-relevant systems.

AS A CSV SPECIALIST YOUR RESPONSIBILITIES WILL INCLUDE, ALTHOUGH NOT LIMITED TO:

• Leading and executing validation activities for new and existing computerised systems, including both bespoke and COTS solutions, in accordance with GAMP 5 principles.
• Performing risk assessments to define the appropriate validation strategy and documentation scope, aligned with the organisation’s overall GxP risk stratification framework.
• Preparing and maintaining validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), validation plans, protocols, reports, and traceability matrices.
• Working collaboratively with IT, QA, system owners, and vendors to ensure systems are implemented, qualified, and maintained in a compliant manner.
• Providing support during audits and regulatory inspections, addressing data integrity and CSV-related queries.
• Ensuring all system lifecycle documentation is maintained in accordance with internal SOPs and GxP standards.
• Assisting in developing implementing and testing disaster recovery plans for key computerised systems in collaboration with business departments.
• Contributing to the continuous improvement of CSV procedures, templates, and best practices.

TO BE SUCCESSFUL IN THIS ROLE, YOU SHOULD BE ABLE TO DEMONSTRATE:

• Bachelor’s degree in a scientific, engineering, or IT-related field.
• Minimum of 3 years’ experience in CSV within the pharmaceutical or life sciences industry.
• Strong understanding of GAMP 5, data integrity requirements, and applicable regulatory frameworks.
• Demonstrated experience with both bespoke and COTS systems across a range of GxP areas (e.g., manufacturing, quality control, clinical operations).
• Excellent written documentation, communication, business process analysis and stakeholder engagement skills.