Facility & Equipment Responsible for CMC Clinical Supplies Facility, IT & Projects

Are you looking for a new challenge where you can apply your extensive knowledge within facilities, equipment and qualification? Do you have a strong passion for managing and validating GxP equipment/systems in a setup that support the growth of the business and ensure the patient safety? And do you want to be part of a growing Clinical Supply Packaging & Shipping (CSPS) where we secure all Novo Nordisk products for clinical trials are packed and delivered to patients all over the world?

If so, read on to find out more about our Qualification- & Equipment Responsible opportunity in Clinical Supply Packaging & Shipping (CSPS) at Site Måløv. Apply now! 

About the position

In this position you will be responsible for the current and future equipment/facilities including HVAC, BMS and FMS. This includes upgrades / rebuild and problem solving, to maintain equipment in validated state and improve their performance. This will involve project management and a motivation to drive LEAN processes to execute systematic problem solving. 

Going forward, the need for implementing new equipment/facilities to support the growth in clinical trials, will also be in the scope of your role.You will collaborate closely with internal and external stakeholder and be part of the project team in a department in constant development with many exciting opportunities ahead of us.

You will be delivering right-first-time solutions with an eye for small details and high quality. This is needed for validation activities, change requests, deviations, documentation etc. so this can be presented in audit situations.

Qualifications

To be successful in this position, you hold a Bachelor, Master or PhD in a relevant area together with extensive hands-on experience within equipment and validation. Ideally you join the team with minimum 5 year’s experience and a background within GxP regulated environment in the pharmaceutical industry. But other regulated industries like aero/space, electronics, plastic production and similar is also durable.

The following experiences will be a plus:

• Microsoft Office, Teams and Planner
• GMP-knowhow / change control / deviation handling
• Management of GxP facilities including troubleshooting, optimisation and handling of critical alarms
• Validation of GxP facilities including HVAC, BMS and FMS
• Project management with technical knowledge
• Stakeholder management cross functionally and with external suppliers

As a professional, you are self-motivated, thrive working independently and enjoy driving projects, improvements, and initiatives across an organisation. You have a structured approach towards challenges and utilise your problem-solving skills to create a standardised way of working. Furthermore, you have a visionary and innovative outlook to drive process optimisation and digitalisation.

Also, you are passionate about the automation and packing machinery industry with a knowledge and interest in future products and solutions.

About the department

The CMC Clinical Supplies Packaging & Shipping (CSPS) department is in Måløv and currently consists of 110 employees divided into six teams. Our overall goal in CMC Clinical Supplies is to ensure timely supply of our clinical studies to patients.

We are responsible for packaging and distributing products for clinical studies and we work closely with the rest of the Clinical Supply Chain at CMC to achieve our ambitious goal of delivering high quality products on time to patients worldwide. We continuously work to optimize our processes, reduce lead time and efficient use of resources using various LEAN tools.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact

For further information about the position, please contact Associate Manager Daniel Bøjle +45 3075 6934.

Deadline

28 April 2024, but please apply as soon as possible as interviews will take place on an ongoing basis.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. Also, please refrain from adding a photo to your CV to ensure an efficient and fair recruitment process.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.