CSV Engineer-Full job Description
Location: Glasgow (Hybrid / Client Site)
Employment Type: Full‑time, Permanent
Salary: £42,000 per annum (based on a 37.5‑hour working week)
Role Overview
Operations Helix Ltd is seeking CSV Engineers to support ongoing digital manufacturing, validation, and compliance projects across life sciences and advanced manufacturing.
The CSV Engineers will provide specialist support for Computer System Validation activities, ensuring that digital systems, automated processes, and data flows remain compliant, reliable, and audit‑ready. This includes authoring and executing validation documentation, supporting system implementations, and ensuring adherence to GxP, 21 CFR Part 11, and EU Annex 11 requirements.
Key Responsibilities
- Perform risk assessments and impact analyses for GxP‑regulated IT and automated systems.
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and internal quality standards.
- Develop and execute validation plans for computerized systems in accordance with regulatory requirements.
- Write and review validation protocols (IQ, OQ, PQ) and associated validation reports.
- Ensure computerized systems are designed, implemented, and maintained in alignment with GMP and data integrity principles.
- Collaborate with cross‑functional project teams to ensure systems are properly validated, documented, and supported throughout their lifecycle.
- Participate in internal and external audits as a CSV subject matter expert, providing evidence and documentation as required.
- Manage validation procedures, change controls, and regulatory compliance activities for computerized systems.
- Support the validation and ongoing compliance of systems such as MES, SCADA, LIMS, ELN, and other digital platforms.
- Work closely with QA and IT teams to maintain audit readiness and ensure robust data integrity across all validated systems.
Skills, Experience & Qualifications Required
- Bachelor’s degree in Computer Science, IT, Engineering, Life Sciences, or a related technical field.
- Minimum 3 years’ experience in Computerized System Validation within a GMP‑regulated environment.
- Hands‑on experience with Commissioning, Qualification, and Validation (CQV) activities.
- Strong understanding of the Software Development Lifecycle (SDLC) and associated documentation.
- Proven experience ensuring regulatory compliance across SDLC deliverables.
- Solid knowledge of validation best practices, including GMP, GAMP 5, and 21 CFR Part 11 requirements.
- Demonstrated track record in the validation of scientific or laboratory software systems
If you meet the above criteria and are looking to contribute to high‑impact digital and compliance projects, we encourage you to apply using the form below.