API Manufacturing Professional for Downstream (Denmark, Hillerød)

Jobbeskrivelse
Placering
Hillerød, Denmark

Jobkategori
Manufacturing

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Do you want to be a part of Novo Nordisk's most significant biopharma investment project at site Hillerød aiming at expanding our Active Pharmaceutical Ingredient (API) capacity? Does the idea of being involved in a new capacity expansion project where you can influence future API production facilities sound interesting?

Once completed the facility we will employ approximately 350 colleagues and feature highly automated and state-of-the-art technologies for new processes and products.

Within Downstream processing we have open positions for API Manufacturing professionals with different levels of experience. Apply now and join us!

The Position
In our team we are currently 15 professionals working as Engineering responsible and Operational responsible with different backgrounds, experience level and nationalities working together to establish two purification lines.

As API Manufacturing professional you will have the role as Operational Responsible (OR) and you will join the project at an exciting time. We are preparing to receive all our downstream process equipment on site, getting ready for installation, planning validation activities as well as all activities required for operational readiness. This include designing the day-to-day operation of the facility, defining procedures, workflows and communication between teams, and process surveillance.

Your key tasks will include:

• Implementing the manufacturing process in our new equipment, software, and automation systems, ensuring that all process requirements are met and continuously monitoring the process to ensure efficiency and compliance.
• Ensuring the facility is ready for operation by preparing Standard Operating Procedures (SOPs) for production and developing training procedures in collaboration with operators and other users.
• Designing the day-to-day operation of the facility, workflows, and communication between teams, and monitoring the process.
• Developing and providing input to protocols for final on-site verification of equipment installation and operation, and executing these tests along with other validation tests in close collaboration with downstream team members, CQV-engineers, and technical disciplines.
• Collaborating with local engineering partners, downstream colleagues, and ER/OR’s from other discipline areas (automation, upstream, utility, logistics) and suppliers to agree on equipment, technical, process, and automation topics related to manufacturing.

When the facility has been fully validated and production has started, you will continue to:

• Ensure stable production of the running manufacturing facility.
• Perform re-qualifications and handle deviations and compliance issues.
• Support operators and maintenance personnel.

In these positions, you will work in collaboration with a wide network of stakeholders, including the Work Package Owner (WPO), local production specialists, IT/Automation specialists, other engineering/operation responsible, operators, and engineering partners.

Some travel activities must be expected.

Qualifications
To succeed in this role, you have:

• An academic degree within engineering, pharmaceutical science or similar
• Experience with working in pharmaceutical production, API production experience is an advantage
• Full professional proficiency in written and spoken English.

As a professional, you like to work independently, take initiative, and have a forward-thinking outlook. As someone who enjoys collaborating, learning, and sharing information with others, you are driven by achieving great results together with colleagues.

Excellent communication and collaboration skills and a positive mindset are essential in this role, making it easier to interact effectively with stakeholders across the organization.

About the department
Our team is working to expand the Active Pharmaceutical Ingredient (API) capacity of our production in Hillerød. You will become a part of one of the most significant expansion projects in Novo Nordisk – and when finished the facility will employ app. 340 colleagues. The highly automated facility will be equipped with state-of-the-art technology that is flexible to accommodate new processes and products. It will expand our capacity for our portfolio of clinical late phase products to serve more people living with serious chronic diseases including rare diseases.

We do not only drive change for our patients – we also drive life-changing careers for our employees by promoting a learning culture with high levels of trust, innovation, and development throughout the organization. To drive the project and reach the initial phase of production, we need your help! Are you ready to join the project team and our journey?

Working in PS API expansion, Novo Nordisk
You will be joining PS API Expansions. 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.

Contact
For further information please contact Manager Helle Baltzer Hattel at +45 3079 7266.

Deadline
27 October 2024. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

We do not require a cover letter, but please include a few sentences in your resume or CV about why you are applying. To ensure a fair and efficient recruitment process, please do not include 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.