16 of 16 21 CFR Part 11 Jobs in the UK excluding London

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

Electrical, Control or Instrumentation Engineering Advantageous Skills, Experience, or Qualifications Strong understanding of cGMP, ISO standards and regulatory expectations for computerised systems, including FDA 21 CFR Part 11 and GAMP5 Direct experience calibrating temperature and pressure instruments Ideal opportunity for a knowledgeable EC&I Engineer from ...

within the medical device industry. Strong knowledge of medical device design, development and Quality Management Systems (QMS). Working knowledge of ISO 13485, FDA 21 CFR Parts 820 & 11, and EU MDR (2017/745). Experience leading internal, external and regulatory audits. Understanding of risk management ...