Operational Responsible for GMP Facilities

Job title:

Operational Responsible for GMP Facilities

Company:

Novo Nordisk

Job description

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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading…CategorySelect how often (in days) to receive an alert:×Select how often (in days) to receive an alert:Operational Responsible for GMP FacilitiesCategory: ManufacturingLocation:Hillerød, Capital Region of Denmark, DKAre you motivated by working in a changing environment? Does the idea of being involved in a new capacity expansion project where you can influence, and impact future API production facilities sound interesting?We are building a new API (active pharmaceutical ingredient) production facility in Hillerød that will employ around 340 colleagues. The highly automated production facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. Apply now and join us at 25L PS API Expansions!The PositionTo meet the future need of our expanding product pipeline we are looking for an Operational Responsible for our GMP storage facilities, who will become a part of one of Novo Nordisk’s most significant expansion projects.You will support the Work Package Owner (WPO) during implementation, testing and validation of the different systems/facilities in scope and when fully implemented, you will be responsible for the daily operation of these systems, ensuring state-of-the-art facilities that supports the production non-stop.Your main responsibilities in the beginning will be to gain deep knowledge about the different systems/facilities in scope such as cold storages, freezer rooms, ambient warehouse, and the FMS (Facility Monitoring System) which monitors all the critical parameters, (temperature, relative humidity, differential pressure), in the areas apart from others like:

• Defining & approving user requirements for storage facilities and FMS.
• Temperature/humidity mapping of storage facilities (cold storages, freezer rooms, warehouse) .
• Performance Verification for facilities in scope including the FMS.
• Process Validation and ongoing monitoring.
• Validation planning and procedures.

This project will give you the scope to be involved in a new, high-profile green field project where you will have the opportunity to be involved in shaping a large new production facility and team.You will be a part of a growing facility team covering the construction phase, qualification phase and bringing the facility into operation and play a key role as OR for the use of the storage facility in the future.This new position as operational responsible covers the responsibility of ensuring the validated state of our storage facilities and you will be travelling within Europe approximately 20 days a year.QualificationsTo succeed in this role, you need to have:

• A relevant academic degree within engineering or similar (candidates with relevant technical background and extensive experience are welcome too).
• At least 5 years of solid engineering experience preferably from Pharma.
• Validation experience from a GMP related area.
• Technical and operational knowledge of GMP regulated facilities as well as about storage facilities and FMS.
• Full proficiency in written and spoken English.

On a personal level you are a driven by your curiosity to learn and feel motivated by finding good solutions to complex problems in a dynamic environment, where you always keep your stakeholders motivated, engaged, and informed.Whilst you can expect a high degree of independence in this position, you also act as a team player with great ability to build strong working relations and collaborate with people across boundaries and share ideas with others, to succeed with the best solution.About the departmentBy becoming a part of the 25L project, you will be joining the PS API Expansions team. The area is anchored in Novo Nordisk Product Supply, Quality & IT, which globally employ approximately 30,000 of Novo Nordisk’s 64,000 employees.PS API Expansions is a newly established and growing area with the responsibility to design, plan and build all major API Expansions projects across Novo Nordisk to serve the needs of millions of patients.We build and design our future API facilities as multi-product facilities with flexibility to accommodate future processes and display state-of-the-art technology and working environment. We focus on delivering the highest quality to patients globally in an efficient and environmentally sustainable way.We are setting the standards for the future, designing facilities we will still be proud of many decades from now. We drive world class execution of capacity projects, and together we are building the future of Novo Nordisk.Working at Novo NordiskAt Novo Nordisk, we don’t wait for a 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.ContactIf you would like to discuss further, you are welcome to contact hiring manager Niki Andersen +45 30798747.Deadline28 July 2024.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. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.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.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Fri, 12 Jul 2024 00:58:10 GMT

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