The EBR Production Support Engineer ensures production continuity by flawless operation and use of the electronic batch reading system. He/she further supports the cartridge production activities and teams in a broad variety of tasks. o EBR administrator: Ensure production continuity by flawless operation and use of EBR First-line contact for operators and supervisors First-line contact for EBR software supplier/developer First-line debugging of EBR and ERP-EBR interfacing Conduct batch record configuration updates Pro-active proposal of system improvements Assessment of requested improvements to EBR, prioritization, impact analysis, solution proposal until partial re-validation o EBR Upgrading and Validation activities: Gathering of new user requirements Writing of qualification protocols, execution of the protocols and writing of qualification reports Keep the validation dossier up-to-date Creation of Work Instructions and training where applicable o Give general support to production personnel: Training follow-up Gowning and cleaning activities and materials Ensure that all direct staff complies with the policies on safety and quality Master or Bachelor in a relevant technical area, e.g. software engineering, chemical engineering, bio-chemistry or you have achieved a similar level by experience. Result oriented and hands-on mentality Self-starter, yet a team-player Good communications skills as well as observational skills Flexible and pro-active mindset Strong problem-solving skills Familiar with following regulations (21 CFR 820 Quality System Regulation, 21 CFR 11 Electronic records & signatures) Familiar with following harmonized standards (ISO 13485 QMS Medical Devices, ISO 14971 Risk Management Medical Devices) Familiar with following guidance ( GAMP 5, GAMP IT Infrastructure and control, AAMI TIR36:2007 Validation of software for regulated processes) Familiar with Agile Software development Familiar with Change Control and Configuration Management Advanced knowledge - orally and in writing - of Dutch and English MS Office Project specific applications; e.g. ERP, SLIMS,… We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young an... Originele vacature is te vinden op StepStone.be - Maak nu een Jobagent aan op StepStone en vind je droombaan! Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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