stillingsbetegnelse: Validation Process Engineer

jobbeskrivelse:
- Production Support - Denmark - Hillerød Device Manufacturing & Sourcing (DMS) seeks a talented and experienced engineer to assist us with validation and qualification activities for injection moulding tools. If you have a great quality mindset, strive for simplicity and possess in-depth knowledge within validation and qualification then apply for this job. About the department DMS is focused on introduction of moulded components for medical devices, maturation of the production setup to excellence and sourcing the components to sister sites abroad. The area is at a high development pace and we need a validation responsible in Mould Pipeline & Validation (MPV), which is a team responsible for sourcing and validation of injection moulds for plastic parts for prefilled devices produced internally in Hillerød DK and on various production sites worldwide. The job You will be responsible for 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 and you will train colleagues and external suppliers worldwide in how to implement the requirements in the validation SOPs in protocols and reports. You will review validation documentation from external suppliers and process confirm that they comply with the requirements. You will support validation engineers in writing, designing and executing validation documents, and you will represent the team in the validation process group in the device area. You will also 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 analyze and resolve the unique situations. You will have a high degree of influence and planning of your own job and daily tasks within the validation activities and we can offer you an international workplace surrounded by talented and dedicated colleagues with whom you can exchange experiences. Qualifications You hold an academic degree, preferable as mechanical, biomedical or validation engineer or similar. You have some experience with validation and/or qualification of production equipment or processes within the pharmaceutical or biomedical industry or other regulated industry. Furthermore, you have a good understanding of GxP, a high quality mind-set and possess excellent communication skills. Communication in English in speech and writing is a necessity. The position includes travel activity that may vary between 20-40 days yearly divided on 1-5 days stays. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Laura Svensson at +45 3075 0463. Deadline 7 April 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Andet ingeniørarbejde (undtagen elektroteknologi)

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark