Stilling
Equipment Qualification Specialist
Jobbeskrivelse
End of 2024, Novo Nordisk acquired the manufacturing site Catalent Anagni S.r.l. with the ambition to expand our capacity to meet the needs of millions of patients. You will be part of a global team that will develop the pharma facilities of the future and work with advanced technology to rethink our fill & finish facilities.
Are you passionate about GMP compliance and ready to take on technical challenges in a fast-paced environment? Join us as a Equipment Qualification Specialist and play a key role in ensuring our facility’s license to operate—driving equipment qualification, supporting CAPEX projects, and shaping future technical solutions, apply now!
The position
This is a key role in our business-critical efforts to ensure and maintain the facility’s license to operate.
Your primary focus will be challenges related to implementation and verification of new equipment as well as general support for the already installed GMP equipment in the facility.
Main responsibilities will be to handle:
- Qualification of new equipment, re-qualification and evaluation on existing equipment
- Support qualification strategies through risk assessment
- Develop and revision technical documentation to support qualification: Validation Plan (VP) and SLIA, DQ, IOPQ Protocols and Reports, Traceability matrices (TM), identification of critical instrumentation, parameters and alarms
- Internal SOP updating
- Managing Deviation and Change related to Qualification Activities
Other areas of responsibility will be supported to existing or new equipment in our non-GMP Facility and laboratories.
Qualifications
In order to succeed in this role, we believe that your profile should be aligned with the bullets listed below.
- Have a master’s degree within life sciences, engineering or similar technical field
- Have at least 2/3years’ experience with equipment qualification within the pharmaceutical industry
- Have in depth knowledge of guidelines and regulations like ISPE, ISO, ANNEX and FDA guidelines
- Are experienced with risk assessment
- Are fluent in Italian and English both written and spoken
On a personal level, you have a positive can-do attitude and thrive in an everchanging environment. You connect easily with all organisational levels due to your excellent communication and people skills. You can quickly create an overview over possible solutions, consequences and needed compromises and you have a passion for setting structure and standards.
We look forward to welcome you in our team!
About the Department
End of 2024, Novo Nordisk acquired the manufacturing site Catalent Anagni S.r.l. with the ambition to expand our capacity to meet the needs of millions of patients. You will be part of Equipment Qualification internal team that will develop the pharma facilities of the future and work with advanced technology to rethink our fill & finish facilities.
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 believe you are qualified, and cannot wait to take the challenge, please upload your CV directly via our online application tool.
Deadline
3 July 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.
