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reference: 4869907

documentId: 4869907

connectionPointId: 7

lastModificationDate: 1535435883573

stillingsbetegnelse: Engineer for equipment & facility support in R&D

jobbeskrivelse:

This position offers an opportunity to be part of a leading Clinical Supplies organisation, where you will be responsible for ensuring equipment and facility qualification compliance.

Last step from production to patient
Chemistry, Manufacturing and Control Development (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 approximately 60 employees divided into 4 teams. The department has over the past years increased the compliance level related to qualification of equipment and facilities. Since the department drives a number of packaging lines and facilities concurrently with re-buildings of both we still have qualifications to do continuously. 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
As Engineer for Equipment and Facility support, it is your responsibility to maintain the packaging facility’s license to operate and ensure that both production equipment and facilities always live up to the required internal and external rules and regulation related to packaging of pharmaceutical products, including validation and documentation work. In particular, you support your colleagues in production with solving complex issues, handling non-conformities, change requests. Additionally, you play a key role in optimisation and changes to the equipment covering tasks such as development and preparation and review of URS, Quality Specifications, validation planning, Risk assessments, Preparing and executing qualifications documents (e.g. IQ, OQ and PQ), System evaluations and similar documentation forming the foundation of our packaging operations.

Finally, you also contribute to or drive projects and present relevant documentation in audit situations.

This position will give you a wide range of practical and theoretical challenges and a unique opportunity to apply and develop your qualifications within packaging production equipment and facility.

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 gained experience with qualification in pharmaceutical production or within an equipment/facility qualification function in a highly regulated industry.

As a person, you enjoy working independently and are keen to take initiatives, set goals, make plans, structure and ensure progress on tasks while collaborating with a broad range of stakeholders. Furthermore, you are eager to have an open and constructive dialogue with staff in the production lines, including presenting ideas and results to all levels of the organisation. Lastly, you have a strong quality mind-set and ensure that all tasks are completed according to expectations.

Working at Novo Nordisk
You will be a part of a highly dedicated team, in which everyone shares the mutual aspiration to further improve the lives of millions of people requiring chronic are.

Contact
If any further information is needed please contact Mikkel Stavnsbjerg on +45 3079 6025.

Deadline
15 September 2018.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2141

abstractJV_contact_0:
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positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: Novo Nordisk A/S

source: DK-STAR