1 to 25 of 29 21 CFR Part 11 Jobs in the UK

equipment and process validation.Understanding of production equipment controlled by PLCs within manufacturing environments.Strong knowledge of GxP regulations, industry standards, and best practices, including 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, and GAMP.Demonstrated experience managing complex validation projects ...

equipment and process validation.Understanding of production equipment controlled by PLCs within manufacturing environments.Strong knowledge of GxP regulations, industry standards, and best practices, including 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, and GAMP.Demonstrated experience managing complex validation projects ...

Previous experience in a regulated (GxP) environmentUnderstanding of GxP regulations and guidelines including but not limited to GAMP 5, US Code of Federal Regs. 21 CFR Part 11 and Part 211, Eudralex Volume 4, Annex 11 & Annex 15, ICH Q7, Q8, Q9 & Q10.Excellent communication ...

driven platform to help advance the treatment of neurological disorders and reduce the uncertainties associated with drug discovery, development and monitoring. As a key part of the global neurological disease research community, the Company has built a global reputation and 20-year track record … software development and validation policies and procedures, ensuring best practice for ‘security & privacy by design’ principles and in compliance with current GCP, FDA 21 CFR Part 11, EU Annex 11, GAMP, FDA QSR Part 820 (QMSR), EU MDR (Regulation 2017/ ...

Summary Solution Leadership and Architecture Lead technical solutioning for MES opportunities as part of the Solution Engineering team. Responsibilities Solution leadership and architecture lead technical solutioning for MES opportunities as part of the Solution Engineering team. Architect design, build, deploy and maintain MES Lite solutions using leading vendor … PLCs, historians, LIMS and cloud platforms. Define scalable application frameworks, reusable components and governance standards. Compliance and Quality: Ensure solutions meet 21 CFR Part 11, Annex 11 and Data Integrity requirements. Partner with Quality and Validation teams to streamline compliant delivery. Business and Practice Development ...

System Administrator (GxP Systems) 3-Month Contract | Part-Time | Pirbright, Surrey | Inside IR35 We're looking for a System Administrator with experience supporting validated systems in regulated environments (GxP/GMP) . Key Responsibilities: System administration, maintenance, and patch management Testing and validation activities (CSV/GxP) System implementation … Change Control & Patch Management Compliance & Audit Readiness System Lifecycle Management CAPA & Risk Management Vendor & Stakeholder Management Project Delivery & Coordination Desirable: GMP, GxP, FDA 21 CFR Part 11, Annex 11 Working Pattern: 2-3 days per week Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio ...

control tools such as Git would be beneficial. Experience working within pharmaceutical, medical device or regulated manufacturing environments would be advantageous. Knowledge of GAMP, 21 CFR Part 11, EU Annex 11 or GMP would be beneficial. Strong communication skills with the ability to work effectively … exciting opportunity to join a growing automation business where you will work on innovative machinery projects within highly regulated industries. You will be part of a collaborative engineering environment that values learning, innovation and continuous improvement. 3P Innovation promotes a culture built around: Innovation challenging assumptions, exploring new ideas ...

connect process development to manufacturing, enabling faster, more reliable tech transfer and batch release. Ensure architecture patterns comply with Life Sciences regulatory frameworks: GxP, 21 CFR Part 11, EU Annex 11, GAMP 5and data integrity requirements. Collaborate with client quality and regulatory affairs teams ...

Programming Git version control Basic electrical, mechanical and pneumatic knowledge Robotics Machine Vision SCADA/MES systems Pharmaceutical or regulated manufacturing environments GAMP, GMP, 21 CFR Part 11 or EU Annex 11 Industrial communication protocols including EtherCAT, Profinet, CAN, Ethernet/IP and Serial communications … .NET and SQL Why Join 3P Innovation? At 3P Innovation, you'll become part of a business built around innovation, collaboration and integrity. You'll work on technically challenging, one-off automation projects where no two days are the same, alongside experienced engineers who genuinely enjoy solving complex manufacturing ...

stakeholder engagement skills. SC Security Clearance (essential). Desirable Experience with SampleManager v21.3. Experience of LIMS upgrade or migration programmes. Knowledge of GxP, FDA 21 CFR Part 11, ISO 17025 or GMP environments. Experience working in regulated laboratory settings. Public sector experience. ...

stakeholder engagement skills. SC Security Clearance (essential). Desirable Experience with SampleManager v21.3. Experience of LIMS upgrade or migration programmes. Knowledge of GxP, FDA 21 CFR Part 11, ISO 17025 or GMP environments. Experience working in regulated laboratory settings. Public sector experience. TPBN1_UKTJ ...

willingness to travel to customer sites Desirable Experience in pharmaceutical, biotech, medical device, food, or other regulated industries Knowledge of GMP, GAMP 5, 21 CFR Part 11, and CSV Experience with validation activities (FAT/SAT/commissioning/qualification) Understanding of industrial cybersecurity Project engineering ...

Serbia, Romania or Poland and can be fully home based in any of those countries.As the Senior Business Analyst you will work as part of our IT Business Engagement & Enablement department and partner closely with business and technical stakeholders to uncover the true needs of the organization and translate … Biotech industry domain experience is desirable.A solid grounding in Business Analysis best practices and consulting behaviors.Familiarity with Computer System Validation (CSV), SDLC methodologies, and 21 CFR Part 11 concepts.Experience working within regulated environments such as pharmaceutical, biotech, or CRO organizations.Experience supporting project delivery within established Project ...

control . Understanding of data integrity, audit trails, electronic signatures and validation within regulated environments. Knowledge of relevant regulatory standards such as GxP, FDA 21 CFR Part 11, ISO 17025 and GMP . Strong problem-solving, debugging, documentation and stakeholder engagement skills, including working with scientists ...

Benchling preferable) or comparable laboratory informatics platform, including schemas, modules and custom workflows. · Understanding of regulatory standards including GxP, ALCOA+ principles, and 21 CFR Part 11 requirements.Desirable:· Knowledge and understanding of the cell and gene therapy industry. · Experience designing and implementing system integrations using APIs ...

technical stakeholders. A practical, commercially aware and solutions‐focused approach. Experience with LIMS, ELN platforms, laboratory systems, GxP, MHRA guidance or FDA 21 CFR Part 11 would be particularly valuable. What’s next? If you are an experienced IT leader who enjoys combining strategy with hands ...

years of experience in Risk Based Quality ManagementRobust understanding of the drug development process and clinical trial executionKnowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)Experience in risk management, sponsor audits and health authority inspections, root cause analyses … addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally ...

Skills and Experience:Knowledge/experience supporting data from Oracle, Salesforce and various data format. Knowledge of government regulations like GxP SEQ, GDPR, and 21 CFR Part 11 or EU GMP Annex 11. Agile/Scrum with experience with JiraExposure to AI, machine learning or advanced ...

wide range of manufacturing and industrial sectors. The Senior Automation Engineer job, based in Dundalk, is a full-time permanent position and will form part of a highly experienced engineering team, supporting the development, commissioning, validation, and ongoing support of automation control systems utilising cutting-edge technologies. Candidates should … Siemens TIA Portal/Step7, OSI PI Historian, or VBA. A thorough understanding of automation principles, control systems, and engineering best practices. Knowledge of 21 CFR Part 11 and GAMP within regulated industries (advantageous). Cisco Networking, VMware, or equivalent qualifications (advantageous). Knowledge of robotics ...

diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel … hosting, security, etc.) in enabling on-premise and cloud IT solutions. Knowledge of data integrity and compliance standards within a GxP-regulated environment (e.g., 21 CFR Part 11). Solution architecture certifications for Microsoft Azure or Google Cloud Platform. Experience working in a product operating model ...

several of the following areas: Security leadership, governance, risk and compliance (GRC) Cloud security architecture and security strategy ISO 27001, GDPR, SOC 2, GxP, 21 CFR Part 11 or similar regulated frameworks Audit leadership, customer assurance and certification programs Healthcare technology, pharmaceutical, biotechnology or regulated SaaS ...

.Experience working with data pipelines and system integrations.Familiarity with scientific or R&D systems (LIMS, ELN, Veeva) is a plus.Understanding of regulated environments (GxP, 21 CFR Part 11) is a plus.Strong problem-solving mindset and ability to manage multiple priorities.Comfortable working in cross-functional and agile ...

investigate and track defects through to resolution Collaborate with engineering, product, applications and quality teams Support release qualification and (where applicable) regulated documentation incl. 21 CFR Part 11 What we're looking for Proven software testing/QA experience (strong manual testing background) Systems-thinking mindset ...

Strong drive, ownership, and execution mindset.### ### **Nice‐to‐Haves*** Experience at a top‐tier consulting firm.* Understanding of regulatory and governance frameworks (HIPAA, 21 CFR Part 11).* Exposure to RWE, biomarker discovery, or trial optimization.* Experience with agentic AI or LLM orchestration in Life … life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.To get there, we seek out diverse talent with curious minds and a relentless commitment ...

/Mathematics degree (MS/PhD preferred) and at least five years of Biostatistics experience, with strong writing and communication skills and familiarity with 21 CFR Part 11, FDA, and GCP #J-18808-Ljbffr ...