Process & Cleaning Validation Specialist

Process & Cleaning Validation Specialist

**Category**:Manufacturing

**Location**:Anagni, Lazio, IT
- 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.

**The position**
- We are seeking a dynamic and technically skilled Process & Cleaning Validation Specialist to join our team. This role is crucial in ensuring the successful validation of new products and processes into clinical and commercial manufacturing.
- Your main responsibilities will include:

- Lead the process/cleaning validation of processes from development to commercial manufacturing, ensuring robust technical documentation and execution
- Develop and monitor process performance, analyzing data to identify trends, troubleshoot issues, and propose improvements or corrective actions
- Interface with external customers and vendors, aligning process requirements, technical expectations, and timelines during transfers and validations
- Support and execute process validation activities, including the preparation of validation documentation, execution of technical batches, PPQ, and ongoing process verification
- Collaborate cross-functionally with internal stakeholders (Quality, Engineering, Production, Maintenance, Procurement) to ensure seamless implementation of new processes and adherence to GMP and safety standards
- This position offers a rich development path, including hands-on experience with advanced technology transfer methodologies, direct engagement with customers and regulatory bodies, and the opportunity to contribute to innovation and continuous improvement initiatives.
- You'll be at the forefront of introducing new processes, simplifying workflows, and driving performance across a high-impact manufacturing environment.

**Qualifications**
- In order to succeed in this role, you:

- Have an academic degree within life sciences, engineering or similar technical field
- Have at least 5 years’ experience with process and/or cleaning validation
- Have gained said experience in the pharmaceutical industry
- Ideally have tech transfer experience and have been involved in audits/inspections
- 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 welcoming you in our team

**About the Department**
- This role offers the opportunity to collaborate not only within your team but also cross-functionally with all site departments in a rapidly growing site and with all sites of Novo Nordisk network. The team had the opportunity to take part to all processes of continuous improvements of existing processes and of new lines under implementation on the site.

**W**orking 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**

**Deadline**
- 16 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.