stillingsbetegnelse:
Validation Engineer in Devices & Supply Chain Management

jobbeskrivelse:
- Production Support - Denmark - Hillerød Device Manufacturing & Sourcing (DMS) in Hillerød seeks a talented individual to assist us with validation and qualification activities for injection moulding tools. We aim for excellent results every day in order to be best in class. If you have a quality mind-set, second to none, strive for simplicity and possess in-depth knowledge or will to learn within validation and qualification, please continue reading. About the department Moulding Support in DMS focuses on supporting production of moulded components for medical devices, maturation of the production setup and support of running production. This field is developing at a fast pace. We therefore seek a validation responsible for Mould Pipeline & Validation (MPV). MPV is a team in Moulding Support, responsible for sourcing and validation of injection moulds for plastic parts produced locally in Hillerød, DK and on various production sites worldwide. We are a team of highly skilled and engaged colleagues. We enjoy what we do and we always strive to do better, all the while having fun. The position You will primarily be responsible for internal validations of injection moulds. You will support all validation activities (Installation Qualification, Operation Qualification and Performance Qualification) performed in Hillerød 24A. You will prepare, evaluate and document the validations according to predefined requirements. You will additionally support and drive projects from a validation perspective in collaboration with stakeholders from DMS and Device Manufacturing & Development (DMD). You will take part in developing and executing strategies for validation of injection moulding tools and related equipment. You will revise and develop local validation SOPs through inputs from validation projects, audits and regulatory authorities. You will support other validation engineers in writing, designing and executing validation documents and you will present validation activities during audits by customers and regulatory authorities; the position requires independent performance and the ability to identify validation requirements, translate these, handle multiple projects simultaneously and analyse and resolve unique situations. You will have a high degree of influence and planning of your own job and daily tasks within the validation activities. We offer an international workplace surrounded by talented and dedicated colleagues, with whom you can exchange experiences. Qualifications You hold an academic degree, preferably as mechanical, biomedical, and/or validation engineer or related fields. You have experience with validation and/or qualification of production equipment and/or processes within the pharmaceutical or biomedical industry or other regulated industries. Furthermore, you have a good understanding of GxP, you possess a “high quality mind-set” as well as excellent communication skills. English communication skills in both speech and writing at a high level are a necessity. Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact For further information, please contact Ida Salinas at +45 3075 2161. Deadline 13 August 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Ingeniørarbejde i industri og produktion

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark