Validation Engineer. HOVEDSTADEN. Dinamarca
Trabajar en Dinamarca (HOVEDSTADEN) de Analistas de gestión y organización
Clasificación del trabajo: Profesionales científicos e intelectuales : Especialistas en organización de la administración pública y de empresas : Especialistas en organización de administración : Analistas de gestión y organización.
Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde, der forudsætter viden på højeste niveau inden for økonomi, administration og salg : Arbejde inden for virksomhedsadministration — privat og offentlig : Analytikerarbejde inden for ledelse og virksomhedsorganisation
Descripción de la oferta de trabajo:
Biogen in Hillerød is looking for a new colleague for the operations team in the Validation Engineering department.
The Validation Engineering department at the Biogen site Hillerod is responsible for the validation of production equipment at site Hillerod. This includes validation of equipment, cleaning, sterilization, chambers, glasswashers and autoclaves as well as running/executing projects. The department consist of 8 FTE’s and a varying number of contractors all based in Hillerod, sharing the responsibilities. We have an open position in the operations team, yet based on your experience and profile, you will have opportunities to impact your own area of responsibility.Primary responsibilities:• Preparing, coordination, executing, driving and reporting validation activities to closure for new and modified bio-pharmaceutical manufacturing equipment in our Drug Substance Production• On-the-floor support to validation execution activities, and general support to manufacturing when needed. • Participate in miscellaneous projects, both with execution and documentation• Investigating validation deviations to determine the impact on the product quality, system operations, and other compliance systems, and supporting general investigations when needed. • Preparing and performing review of validation, engineering reports as well as review of URS, FAT/SAT documents, commissioning plans and reports, and operational/validation procedures to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology. • Providing SME guidance and assessments on validation impacts and requirements when equipment and systems are subject to modifications or changes. • Preparing and reviewing technical reports, risk assessments, annual regulatory validation summary plans and reports related to equipment and products etc • Participate actively in audits and regulatory inspections, prepare audit responses and tracking sheets, compile and write status reports• Support to manufacturing improvements as needed*LI-DEN2
The successful candidate will have knowledge of the business as well as a proactive, outgoing and highly enthusiastic behavior to the job. You are used to leading your own projects, have a profound sense of responsibility and are used to taking ownership as well as leadership. A high level of persistency, drive and service combined with a strong commitment and attention to detail is crucial to succeed in the job. The Validation Engineer, must be able to navigate in a multi-cultural environment and must have excellent communication skills. The ideal candidate is highly self-motivated and can direct others at both tactical and strategic levels, in a busy environment. You are flexible as manufacturing runs 24/7/365You have experience within several of the following areas:• Experience in pharmaceutical or biotech manufacturing environment, preferably with purification• Knowledge and experience with cleaning validation (CIP) preferably sterilization validation (SIP), utilities validation (water/steam/gasses)• Basic engineering knowledge, able to trouble-shoot engineering issues • Commissioning and automation validation knowledge• In-depth knowledge of biopharmaceutical equipment and process technologies and clean utilities • Competency in MS Word, MS Excel, MS Power Point and MS Project • Excellent oral and written communication skills in EnglishAs a person you are able to manage several tasks simultaneously as well as enjoy being part of a busy and dynamic environment where the working morale is high.
The ideal candidate carries a Bachelor of Scie
Servicio de empleo de origen: AMS, Servicios Públicos de Empleo, Dinamarca.
País del trabajo: Dinamarca.
Fecha de inicio: 01/06/2018.
Nº de vacantes: 1.
Nivel educativo requerido: Sin especificar.
Cómo solicitar el puesto: Connie Jakobsen
Empresa: BIOGEN (DENMARK) NEW MANUFACTURINGApS.
Contacto: Johannes Mols
Ver las 265 ofertas de trabajo de Profesionales científicos e intelectuales : Especialistas en organización de la administración pública y de empresas : Especialistas en organización de administración : Analistas de gestión y organización ofertadas.
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