EBR Production support engineer

Posted on Dec 12, 2018 by Synergie Belgium nv

Mechelen, Antwerpen Belgium
Immediate Start
Annual Salary
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!
Original job ad is published on StepStone.be - Set up a Jobagent at StepStone now and find your dream job! For similar jobs, information on employers and career tips visit StepStone.be!
La version originale de cette offre d'emploi est disponible sur stepstone.be - Créez maintenant votre Job Agent sur StepStone et trouvez le job de vos rêves ! Trouvez des jobs similaires, des informations sur les employeurs qui recrutent et des conseils de carrière sur stepstone.be!

Reference: 599568815

Similar Jobs


Mechelen, Antwerpen Belgium


UX Designer

Mechelen, Antwerpen Belgium

Digital Devils BVBA

Commercial Financial Planning & Analysis Analyst - Meche

Mechelen, Antwerpen Belgium

Robert Half Finance & Accounting

Project Ingenieur

Mechelen, Antwerpen Belgium