Manage GxP Area Process Manager

Are you looking for an opportunity to work in Manufacturing Development? Would you like to develop your career within environmental monitoring (EM) and process management? and would you like to have an impact in a broader perspective? If yes, then do not miss this opportunity to boost your career and apply today!

The position
You will work closely together with a team of experts and specialists covering all aspects of the aseptic production processes across Biotech & Rare Disease (BRD) and other SVP areas in Product Supply (PS). The team fosters an open professional attitude, supporting each other’s growth . The Manage GxP regulated Facility process cover environmental monitoring, gowning and behaviour in classified area, cleaning of production facilities and contamination control with the purpose of establishing, operating, and maintaining facilities and environment used for manufacturing. In this role, you will play a special part in:
• Facilitating Process Group meetings in BRD.
• Participating in the work to Improve and Future proof the cleanrooms across [xxxxx].
• Supporting and troubleshooting at our production sites across our SVP-area incl. new facilities.
• Managing smaller projects within the process.
• Ensuring that best practices are identified, shared, and implemented across the sites.
• Interpreting GxP requirement into practice.
• Participating and execute training in the process (peer-to-peer and classroom training). We have a strong focus on making a difference in close collaboration with the production sites and you will be involved in making key decisions within the EM area across production sites in BRD, so you need to have the ability to solve complex issues in the production. You will have a broad range of contacts, e.g. with production departments, QA, QC, and process responsible across PS. To a very large extent, your success depends on your ability to collaborate and communicate in a transparently.

Qualifications
To succeed in this position, you should have:
• MSc in Microbiology/Chemical/Pharmacy/Engineer or similar field.
• +5 years of professional experience working in an AP production facility.
• Knowledge related to environmental monitoring requirements and related guidelines.
• Ability to communicate effectively at all organisational levels from operators to managers and specialists.
• Proficiency in both written and spoken English, with an advantage if you are also proficient in Danish. You can expect a position with a high degree of independence, where strong communication skills are a must, This includes the ability to establish relationships and influence colleagues across the organisation to ensure buy-in for new approaches. About the department
Manufacturing Development is a part of Biotech & Rare Disease (BRD) with a team of over 650 colleagues working together to optimise and develop processes across six global production sites. Our field of work broadly covers the area also known as MSAT (Manufacturing, Science, and Technology). We bring value to our patients by driving innovation for the entire BRD, working with Industry 4.0, new technologies, biotechnology, and developing processes for both existing and future products.
Working at [xxxxx], Biotech and Rare Disease (BRD)
Biotech & Rare Disease (BRD) is part of [xxxxx] Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all [xxxxx] products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for [xxxxx]. We are more than 3000 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support [xxxxx]'s initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology. Contact
For further information, please contact Thais Vilgren, Sr. Specialist, +[xxxxx]or Camilla Aasholm Bradley, Senior Manager at +[xxxxx].

Deadline
21 April 2024.

Please be advised the interviews will be conducted on an ongoing basis, so we encourage you to apply as soon as possible. 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 [xxxxx] 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.