9 of 9 Permanent GxP Jobs in the East of England

integration patterns. Document application behavior, technical designs, and operational procedures. Ensure solutions align with healthcare privacy, security, and regulatory expectations including HIPAA, GDPR, and GxP-aligned practices where applicable. Mentor other engineers and contribute to engineering standards, code quality, and technical best practices. Required Knowledge, Skills and Abilities Strong proficiency ...

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 ...

particularly Emerson DeltaV, and HMI/SCADA platforms.Strong knowledge of process instrumentation principles, calibration techniques, troubleshooting methodologies, and industrial communication protocols.Experience working in a GxP/cGMP regulated environment, with knowledge of computerized system validation (CSV) principles.Ability to interpret P&IDs, electrical schematics, and technical documentation, with excellent problem-solving ...

Provide pathology oversight of assay performance, result review and reporting practices in an accredited environment supporting clinical and biomarker development. - CAP/CLIA and GxP Compliance: Act in a role aligned to CAP/CLIA expectations; ensure testing and reporting practices meet regulatory and professional standards, including ...

medical devices. You will align global standards with business objectives and oversee submissions to regulators and notified bodies. The role requires deep expertise in GxP, ISO standards and clinical compliance. You will partner with Clinical Operations, IT and Engineering to embed regulatory and quality requirements into digital #J-18808-Ljbffr ...

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 ...

applicable regulations, and internal quality standards. Lead the implementation, improvement and validation of new processes, procedures, and IT systems (e.g., eQMS, eTMF) to support GxP compliance and operational excellence. Oversee internal and external audits, including regulatory inspections, ensuring findings are addressed promptly and effectively. Partner with Clinical Operations, IT, Engineering … Science Teams to integrate quality and regulatory requirements into digital platforms, AI-enabled solutions, and GxP-relevant systems. Embed a culture of quality awareness through training, workshops, and mentoring, ensuring all staff are competent and compliant with GCP, ISO standards, and internal policies. Support the Quality Manager in maintaining ...

preparation and delivery of user training, management of technical documentation, enhancement of system capabilities, and collaboration with cross-functional teams. Responsibilities include supporting GxP -compliant system validation activities, user acceptance testing, and participation in regulatory inspections and internal audits as needed. The Associate Director will work directly with business stakeholders … development support. Oversee system lifecycle activities including requirements gathering, design, testing, validation, deployment, and ongoing support. Ensure delivery of high-quality solutions that meet GxP , regulatory, security, and data integrity requirements. Partner with Quality and Validation teams to support system validation, audit readiness, and inspection activities. Drive continuous improvement initiatives ...