Overview

CSV Specialist / Systems Validation Engineer - Glasgow - Circa 50K plus bonus

Lorien’s client, a rapidly growing organisation with bases across the UK and overseas providing life-saving products to people around the globe, is looking to secure the services of a CSV Specialist / Systems Validation Engineer to take ownership of validation activity across multiple regulated systems, working at the intersection of IT, Quality, and Operations. This is a site-based role reporting into the Head of IT, with close collaboration with senior quality representatives and others.

This is a great chance to join a fast-moving, growth-focused organisation that’s deeply committed to its mission, work in a collaborative environment with influence across multiple business units, and play a pivotal role in ensuring quality, compliance and continuity across core IT systems.

Responsibilities

• Coordinating and carrying out validation for both custom-developed and commercial off the shelf systems used across regulated environments
• Supporting lifecycle management from planning onwards, ensuring documentation and compliance remain watertight
• Conducting risk assessments to determine validation scope and strategy based on Good Practice relevance
• Creating and maintaining validation documentation such as user/functional requirements specs/validation planning/protocols/reports/etc.
• Liaising with internal teams and vendors to deliver compliant system implementations aligned to Good Automated Manufacturing Practice and agreed standards
• Acting as a key contact for audit and inspection activity concerning data integrity and system validation
• Taking part in DR testing for critical systems and assisting with contingency planning
• Helping evolve internal policies, templates, and working practices to keep pace with regulatory expectations

What You’ll Bring

• Proven background in a similar role/s in IT/Engineering/Life Sciences/similar domains
• Familiarity with regulatory frameworks including Good Automated Manufacturing Practice and similar relevant offerings
• Track record of working with both custom and off-the-shelf platforms in regulated (GxP) environments — such as in manufacturing, QC or clinical settings
• Confidence working across departments and communicating with technical and non-technical audiences

To learn more or apply, please send your CV and arrange a chat with the recruitment team. This is a site-based role based in Glasgow.

Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Information Technology
• Industries: IT System Testing and Evaluation

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