stillingsbetegnelse: Qualification and Equipment Responsible Supporter

jobbeskrivelse:
- Production Support - Denmark - Måløv We are looking for 2 qualification & equipment responsible supporters to join our department and join us in ensuring our packaging lines run on a day-to-day basis contemporary with planning and execution of project related to the lines. Last step from production to patient Chemistry, Manufacturing and Control Devolopment (CMC) is a part of the Research & Development organisation, manufacturing and distributing drug candidates for pre- and clinical trials. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. CMC Development is organised in seven areas of expertise supporting the entire drug development pipeline. Working in CMC Development, you’ll be part of a team of the best and brightest in your field, where scientific integrity is standard and shared responsibility taken for granted. About the department Clinical Supplies Packaging & Shipping is the department in CMC Development responsible for the last part of the production before the patients receives the products. We pack and ship products to clinical trials all over the world. The department has expanded a lot the last couple of years and at the moment it consists of approx. 75 employees divided into 4 teams. The department has increased the number of packaging lines to 3 the last year and is still expected to experience a lot of changes regarding the equipment and the processes related to the lines going forward. This is to be done while we still need to deliver products to the trials in the right quality at the right time. The position You will be responsible for ensuring the packaging lines comply with current equipment qualification requirements. Some of the main themes to secure this are setting the right equipment qualification goals and implement the right initiatives to reach these goals in collaboration with the management team. This requires solid technical understanding on how packaging equipment controls barriers works especially regarding Vision systems. Tasks such as development and review of User requirement specification (URS), quality specifications, validation planning, risk assessments, preparing and executing qualifications documents (e.g. IQ, OQ and PQ) and similar documentation forming the foundation of our packaging operations are a typical part of your responsibility. As an expert on packaging you will furthermore be part of our day-to-day support of our production. Here you provide expert input on how to solve non-conformities, change requests, and help our production address, the many challenges faced by a clinical packaging production. You will act as either project manager or project member in projects with technical aspects. This will include activities to set a standardised level of qualification/validation on all equipment and facilities. You will also be responsible for presenting relevant documentation in audit situations. Qualifications You have a relevant education, preferably academic, such as M.Sc. in Engineering or similar preferably with a mechanical focus. It is required for you to have experience working with qualification in pharmaceutical production or an equipment/facility qualification function in a highly regulated industry. You possess assertiveness and are able to set and communicate goals followed by a structured approach to reach these goals. Collaboration in a broad perspective is a must since both daily dialogue with staff in production and broad stakeholder management is required. Working independent must be a part of your preferred working environment. Working at Novo Nordisk 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. Conta

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