Regulatory Engineer- Medical Devices
1 settimana fa
We are seeking CSV Engineers with 2-5 years' experience and 2 years' experience in GMP environment.About CAICAI is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.Meeting a Higher StandardOur approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:We act with integrity.We serve each other.We serve society.We work for our future.With employee ownership, one person's success is everyone's success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.Position Description:The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.Position Requirements:BS in a Computer Science or Engineering field or equivalent experience2-7 years' experience with Computer systems validation2 years' experience working in a GMP environmentExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desiredExperience in biotech and pharma is preferred over medical deviceExperience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.Other Requirements:Excellent oral and written communication skills in English/Fluent in EnglishAble to travel domestically and internationally as requiredLa selezione rispetta il principio delle pari opportunità (l. 903/77)#LI-AG1
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Quality & Regulatory Specialist - Medical Devices
1 settimana fa
Bologna, Italia HOEL Consulting A tempo pienoPMI altamente innovativa che progetta e produce dispositivi elettromedicali, depositaria di brevetti ed attiva nei mercati internazionali, ricerca per assunzione diretta un/a **QUALITY & REGULATORY SPECIALIST - MEDICAL DEVICES** **Descrizione **ruolo**: La figura sarà responsabile degli aspetti di qualità aziendali relativi, con il supporto di una figura...
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Quality & Regulatory Specialist - Medical Devices
1 settimana fa
Bologna, Italia Hoel Consulting s.a.s. A tempo pienoPMI altamente innovativa che progetta e produce dispositivi elettromedicali, depositaria di brevetti ed attiva nei mercati internazionali, ricerca per assunzione diretta un/a: **QUALITY & REGULATORY SPECIALIST - MEDICAL DEVICES** La figura sarà responsabile degli aspetti di qualità aziendali relativi, con il supporto di una figura junior. Nello...
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Process Validation Engineer
4 settimane fa
Bologna, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? La possibilità di lavorare su progetti per le più importanti aziende farmaceutiche nazionali e internazionali, acquisendo competenze trasversali e una visione ampia del settore. Il vantaggio di accrescere rapidamente la...
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Process Engineer
3 giorni fa
Bologna, Italia PQE Group A tempo pienoEntrare in PQE Group significa mettere la propria esperienza al centro di progetti strategici per i leader globali del settore Life Sciences.Dal 1998 PQE Group è un punto di riferimento internazionale nella consulenza per l’industria farmaceutica e dei Medical Device . Con una presenza consolidata in Europa, Asia e Americhe, 45 filiali e oltre 2.000...
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Process Engineer
4 giorni fa
Bologna, Italia PQE Group A tempo pienoEntrare in PQE Group significa mettere la propria esperienza al centro di progetti strategici per i leader globali del settore Life Sciences. Dal 1998 PQE Group è un punto di riferimento internazionale nella consulenza per l’industria farmaceutica e dei Medical Device. Con una presenza consolidata in Europa, Asia e Americhe, 45 filiali e oltre 2.000...
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Senior Specialist: Qa&Ra Medical Devices
6 giorni fa
BOLOGNA, Italia Nonstop Consulting A tempo pienoNuova opportunità nel settore Medical Devices!Il nostro cliente è una realtà innovativa e in forte crescita, con sede in provincia di Bologna e una solida presenza sui principali mercati internazionali.L'azienda sviluppa dispositivi elettromedicali registrati con successo come dispositivi medici attivi e certificati secondo i più alti standard:FDA, CE...
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Regulatory Affairs Specialist settore farmaceutico
1 settimana fa
Bologna, Italia Alfasigma S.p.A. A tempo pienoA leading global healthcare company in Bologna is seeking a Non-Pharma Global Regulatory Affairs Specialist. This role involves managing regulatory documentation and supporting submissions for various projects across EU and other markets. The ideal candidate should have over 5 years of experience in Regulatory Affairs, preferably in food supplements or...
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Global Regulatory Affairs Specialist
4 giorni fa
bologna, Italia Alfasigma S.p.A. A tempo pienoA leading global healthcare company in Bologna is seeking a Non-Pharma Global Regulatory Affairs Specialist. This role involves managing regulatory documentation and supporting submissions for various projects across EU and other markets. The ideal candidate should have over 5 years of experience in Regulatory Affairs, preferably in food supplements or...
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Regulatory Affairs Specialist – Medical Devices
3 settimane fa
bologna, Italia Page Personnel A tempo pienoUn'agenzia di selezione personale è alla ricerca di un Regulatory Affairs Specialist per un'importante realtà dinamica in Emilia-Romagna. Il candidato ideale avrà una formazione in ingegneria elettronica o meccanica e almeno 2 anni di esperienza nel settore regolatorio dei dispositivi medici. Le responsabilità includono il monitoraggio degli...
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Regulatory Engineer
2 settimane fa
Bologna, Italia Zobele A tempo pienoPart of kdc/one, Zobele is a multinational, global leader in product development and manufacturing, key partner of the top Home & Personal Care FMCG´s companies . To meet our growth challenges we’re looking for proactive, enthusiastic and talented professionals willing to join our team. Our HQ in Trento ( Italy ) is currently looking for...
