Environmental Supporter at CMC API Pilots (Denmark, Bagsværd)

Jobbeskrivelse
Placering
Bagsværd, Denmark

Jobkategori
Engineering & Technical

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Are you passionate about ensuring quality and compliance in a dynamic pharmaceutical environment? Do you have the skills to ensure our production environment meets regulatory standards while collaborating with diverse teams?

If so, we want to hear from you! Apply today for a life-changing career and join us as an Environmental Supporter at CMC API Pilots.

Get introduced to CMC API Pilots and meet our employees by visiting our career site.

The position
We are looking for a passionate and independent Environmental Supporter for our Support team, who will be responsible for environmental monitoring of pilot plants at API Pilots.

As part of the team, you will play an important role in ensuring the quality of our products and complying with regulatory requirements.

We need to ensure that the environment in which we produce is under control and complies with our regulations.

Your tasks will include:

• Monitoring the environment, deviation work for the different pilot plants, and the associated documentation (PEMS work, reviewing logbooks, etc.).
• Preparation of change requests, trend reports, and annual reports for environmental monitoring (microorganisms and particles).
• Qualification (PFV) of classified areas in connection with modifications in CMC API Pilots.
• Ensuring compliance with new requirements.
• Participation in the process group S2.03 Manage GxP regulated Facility.

You will be the environmental responsible, which means you will be responsible for ensuring that one of our plants is in control of the environment.

Qualifications
To thrive in this role, you have:

• An academic degree in Biochemistry or similar.
• Experience in the pharmaceutical industry and knowledge of GMP is considered as an advantage.
• Relevant experience of process equipment and production from similar or related fields is preferred but if you are a recent graduate we would like to hear from you as well.
• Ongoing development of your knowledge through courses and other education is essential for being able to perform in the position
• Proficiency in English, both written and spoken.

The job involves a high degree of collaboration with your colleagues in the team, colleagues in the pilot plants, and cleaning staff. To succeed in the role, it is essential that you work well with many different types of people, both within the team and across the organization.

As a person, you are proactive and independent, and you take the initiative to solve tasks, even when they are not directly presented to you. You have a positive attitude towards your work and are eager to take on tasks you haven't tried before.

About the department
As part of the Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture, and distribute drug candidates for clinical trials and have a strong culture with a “can do” mindset.

Our department, CMC API Pilots Operations, consists of over 84 employees and is organizationally placed within the area of Chemistry, Manufacturing and Control (CMC) API Pilots, which has around 500 employees. Here, the production of APIs (Active Pharmaceutical Ingredients – the drug substance) for clinical trials takes place, along with the process development of new API candidates.

You will be part of a Support team of 15 skilled and dedicated employees who support all pilot plants in API Pilots in relation to Environmental Monitoring (EM), monitoring of Clean Utilities (purified water and gases), as well as cleaning of classified areas. Our team is responsible for ensuring that quality is top-notch and that we meet regulatory requirements. The expertise in the team is high, and we work with a strong 'can-do' attitude when it comes to solving the challenges that arise. Since the pilot plants frequently switch API campaigns, there is a great variety in the challenges we face as a team.

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
If you would like to know more about the position, please contact Manager Tim Andersen at +45 30751455 or [email protected].

Deadline
5 January 2025

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.