12 of 12 GAMP Jobs in the UK

endpoint management solutions Experience working within a pharmaceutical, biotechnology, medical device or similarly regulated environment would be highly desirable An understanding of GxP, GMP, GAMP 5, Annex 11 and 21 CFR Part 11 would be advantageous Strong understanding of IT service management and ITIL principles Excellent analytical and troubleshooting skills ...

Object-Oriented 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 ...

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 2017/745), IEC 62304, GDPR, ISO 13485, ISO 27001 and ISO 42001/EN 18286 regulatory ...

Object-Oriented 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 ...

BI. Highly analytical and data driven. Experience in reviewing and maintaining system architectures, standards, change control procedures, and system backups. Understanding of cGMP, and GAMP principles including validation, change control, documentation, and compliance requirements for automated manufacturing systems. Experience with system integration involving MES, ERP, and other third‐party platforms. ...

requirements gathering, risk assessments, validation planning and test execution. Maintain documentation including SOPs, validation records, configuration specifications and change records. Ensure compliance with GMP, GAMP 5, Annex 11, 21 CFR Part 11 and company quality procedures. Support internal audits, external audits and regulatory inspections. Project and Vendor Management Work with … pharmaceutical, biotechnology, medical device or similarly regulated environment is highly desirable. ITIL Foundation, Microsoft Certifications, CompTIA Network+, CompTIA Security+, VMware Certification, Cybersecurity or GAMP/CSV related training preferred. Key Competencies Strong analytical and troubleshooting skills Excellent communication Customer focus Attention to detail Documentation capability Ability to manage priorities Stakeholder ...

Degree in Mechanical, Electrical, Mechatronics, or Automation Engineering (or equivalent hands-on experience). Pluses: Robotics integration (6-axis/SCARA), ISO 13485/GAMP knowledge, or Six Sigma training. ...

hearing from engineers with Intermediate to senior (5+ years) CSV (full lifecycle) experience. CSV experience of process equipment manufacturing API Strong knowledge of regulations (GAMP 5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices Experience of working with software/automation validation in a project environment. ...

hearing from engineers with Intermediate to senior (5+ years) CSV (full lifecycle) experience. CSV experience of process equipment manufacturing API Strong knowledge of regulations (GAMP®5 and 21 CFR Part 11, Annex 11) and modern CQV CSV practices Experience of working with software/automation validation in a project environment. ...

projets d’investissement et d’automatisation, assurant la fiabilité et la performance des systèmes industriels et des laboratoires, tout en respectant les exigences GAMP et les standards de qualité. #J-18808-Ljbffr ...

clean utilities (Purified Water, WFI, Pure Steam, Compressed Air, HVAC) and/or process equipment (Fermenters, Bioreactors, Filling Lines, Autoclaves). Strong knowledge of GAMP 5 , ASTM E2500 , and 21 CFR Part 11 compliance. Proficiency in using standard C&Q documentation software and calibration tools. Expertise in CSV (Computerized System … Validation) for automation systems, including validation of ERP, MES, SCADA, and laboratory systems (e.g., Empower, LabWare) per GAMP 5 guidelines. Experience with DeltaV, Siemens PCS 7, or similar BMS/EMS systems is a plus. Six Sigma or Lean methodologies are advantageous. Flexibility: Must be comfortable with immediate mobilization ...

projects including defining the validation requirements to ensure compliance with MHRAs Orange Guide, EU's EudraLex Vol. 4, USA's CFRs, ISO, ICH, GAMP and PIC/S. CSV Engineer is able to perform computer systems validation who will implement best practices for system implementation as per GAMP 5 guidance. … Data Integrity (DI) requirements for regulated industries and its development life cycle approach (E) Strong technical authoring skills (E) Thorough knowledge of cGMP & GAMP as applied in biopharmaceutical or related industry (E) Proven ability to meet timelines, prioritise tasks and engage with stakeholders (E) Good communication skills and the ability ...