stillingsbetegnelse: Validation Process Engineer

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 job You will be primarily responsible for the qualification of our external suppliers worldwide, training them how to implement requirements in the Novo Nordisk validation SOPs. You will review validation documentation from our external suppliers and perform process confirmation of external suppliers, to ensure they comply with the requirements.You will additionally 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 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. The position includes travel activity ranging from a few days to several months at a time. Therefore, flexibility is a highly valued requirement for this position. At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us, you will have the opportunity to do the same in a global business environment. Contact For further information, please contact Jacob Ørting at +45 3075 2991 or Ida Salinas at +45 3075 2161. Deadline 15 February 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