Working with TCP/IP and resolving general networking issues. Experience: Extensive IT/Commercial experience gained within a fast-paced environment? Experience of GAMP 5 and working within a GxP environment in providing superior customer service and support. Experience of working within a technical support position, covering Windows, Microsoft more »
Warwick, Warwickshire, West Midlands, United Kingdom Hybrid / WFH Options
Orion Electrotech Automation
knowledge and experience Basic knowledge of mechanical and pneumatics principles Beckhoff/Siemens control systems experience Experience working in the pharmaceutical industry Familiarity with GAMP/21CFR11/Eu Annex 11/GMP Experience with developing Robots, Machine vision, SCADA/MES Experience working with communication protocols e.g. EtherCAT, Profinet more »
Responsibilities Oversight and Compliance : IT CSV oversight for GXP computerized systems. Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5). Handling deviations, CAPAs, and change controls. Documentation and Review : Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/ more »
Responsibilities Oversight and Compliance : IT CSV oversight for GXP computerized systems. Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5). Handling deviations, CAPAs, and change controls. Documentation and Review : Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/ more »
We are looking to recruit an experienced Computer Systems Validation Engineer who has a good knowledge of Gamp 5 guidelines, 21 CFR and Anex 11 regualtory standards. You will ideally have gained experience as a CSV Engineer in either the Bio Technology or Pharaceutical sectors. You should be able to more »