Facility & Equipment Responsible for CMC Clinical Supplies Facility, IT & Projects
1 month ago
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.
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 suppliersAs 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.
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