3 of 3 GxP Jobs in Stevenage

small team and/or external partners, providing technical guidance, quality assurance and stakeholder updates while ensuring compliance with data governance, quality and GxP requirement. Required Qualifications & Skills Bachelor’s degree or equivalent in Computer Science, Data Engineering, Data Science, Bioinformatics, Software Engineering, Life Sciences, or a closely related scientific ...

inclusive environment for all employees. Role Summary This is a hands‐on senior engineering role with ownership across the computerised-system lifecycle, from initial GxP impact and supplier assessments through validation, release, operation, periodic review and retirement. The successful candidate will partner with Quality, Manufacturing, Engineering, IT, and system owners …/Cloud based systems validation utilising modern CSA approach. (E) Understanding of validation/assurance of AI and ML enabled systems, preferably in a GxP environment. (P) Strong technical writing and communication skills. (E) Experience of having supported FDA, MHRA, EMA or any other regulatory Audit inspections. (E) Qualifications Minimum ...

environment, supporting mission‐critical applications that enable research, clinical processes. The role has a direct impact on compliance with global regulatory standards (e.g., GxP/CSV), ensuring system reliability, and uninterrupted delivery of ongoing innovation initiatives. You will work on complex, integrated platforms leveraging modern engineering practices and tools (e.g. … system integrations, ensuring timely issue resolution. Drive end-to-end compliance activities including validation documentation, audit readiness, and adherence to regulatory standards (CSV/GxP). Oversee multiple concurrent workstreams with competing priorities in resource-constrained environments, ensuring optimal delivery outcomes. Proactively manage risks, issues, and schedule pressures, implementing mitigation ...