6 of 6 21 CFR Part 11 Jobs in the South East

accelerate discovery while protecting data integrity, compliance, and multi-tenant unit economics. This position reports to the Senior Director, Platform Product Management and is part of the Platform Product Team and will be an office based role (based in the UK), however a remote position will be considered … data contracts across ELN, spreadsheet, and inventory data. Govern Compliance, Security & Unit Economics: Ensure permission-aware retrieval and tenant isolation by design (supporting 21 CFR Part 11 and GxP standards) while monitoring token economics, latency, and quota utilization per tenant. Drive Customer Adoption & Validation: Collaborate with ...

party integration developments, and emerging customer expectations around connectivity, data management, and regulatory compliance Partner with Strategic Segment Managers to understand how regulatory requirements (21 CFR Part 11, GAAMP, OECD GLP) affect software product needs in priority end markets Translate hardware NPI requirements into software specification … relevant scientific discipline — providing credibility with scientific end users and technically specialist R&D teams Experience with regulatory software requirements in analytical instrument markets: 21 CFR Part 11, GAAMP, GLP/GMP compliance, or equivalent Familiarity with laboratory informatics ecosystem: LIMS, ELN, data management platforms ...

Data Integrity Ensure laboratory connectivity and integration solutions meet applicable GxP requirements and organizational quality standards. Apply relevant requirements and principles, including FDA 21 CFR Part 11 and EU GMP Annex 11 where applicable, ALCOA+ data integrity principles, and Good Documentation Practices. Support requirements definition ...

machine controls .Experience with machine vision and automated inspection systems .Knowledge of serialization and aggregation requirements and associated Level 1–4 packaging architecture.Familiarity with 21 CFR Part 11, electronic records/electronic signatures, dataintegrity, and computerized system lifecycle principlesUnderstanding of packaging-related quality considerations such … introduction, technology transfer, scale-up, and commercial manufacturing readiness.Ability to quickly learn new equipment, technologies, and manufacturing processes.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative , consistent with the language in the existing role.As part ...

IDBS, part of Danaher, seeks a Principal Product Owner for AI to own the AI backlog on the Polar platform and translate RAG capabilities into grounded scientific workflows. This UK-based, office-based role may consider remote arrangements for the right candidate. You will drive backlog, coordinate with … data eng and UX, and ensure compliance with 21 CFR Part 11 and GxP while optimizing tenant economics and latency. #J-18808-Ljbffr ...

technologies.* Strong software engineering and development experience including software development, issue management, DevSecOps, continuous integration, or cloud deployment.* Experience with software development for 21 CFR Part 11-compliant or regulated environments would be advantageous. **Soft skills:*** Proven leadership, strong communication and interpersonal skills. **Additional Details**This ...