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lastModificationDate: 1539164587126

stillingsbetegnelse:
Dynamic Engineer for equipment and facility support on packaging lines

jobbeskrivelse:

Are you interested in taking the technical responsibility for equipment and facility on high performing packaging lines in a leading Clinical Supplies organisation? This position gives you a unique chance to use your technical flair and be a part of a dynamic team that works to ensure that both the equipment and the facility perform in compliance with relevant regulation and delivers high quality products to our clinical trials patients. 
 

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 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 regulations related to packaging of pharmaceutical products. This position will give you a key role where you can balance both operational daily support and exciting projects where you can apply and develop your professional qualifications within packaging production equipment and facility.

 

To ensure that the equipment and the facility are ready for production, you will be a part of the daily support and contribute with your expert knowledge to support your colleagues working on the packaging lines with solving complex issues, handling non-conformities and change requests.

Additionally, you contribute to or drive exciting projects such as regular rebuilding of the lines to pack new products and present relevant documentation in audit situations. In particular, you play a key role regarding 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.

Qualifications
You have a relevant academic education, preferably a M.Sc. in Engineering with a mechanical focus or similar. You have gained experience with both validation and qualification in pharmaceutical production or within an equipment/facility or technical support function in a highly regulated industry. The role also requires that you master both written and spoken Danish and English. It is an advantage if you have experience with packaging production lines and equipment and/or with transport qualification.

As a person, you enjoy working independently and are keen to take initiatives, set goals, make plans, structure and ensure progress on your tasks while collaborating with both internal and external stakeholders. Furthermore, you are eager to have an open and constructive dialogue with colleagues in the packaging production lines, and you enjoy presenting ideas and results to all levels of the organisation. Lastly, you have a strong quality mind-set and ensure that all tasks/projects 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 care.
 
Contact
If any further information is needed please contact Mikkel Stavnsbjerg on +45 3079 6025.
 
Deadline
14th of October 2018.

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

numberOfPosts: 1

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

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: Novo Nordisk A/S

source: DK-STAR