Validation Responsible

Are you passionate about validation and building relationships across the organization? Are you interested in being a part of something bigger than yourself and contribute to the health of millions of people worldwide? We are seeking a detail-oriented and experienced professional to fill the combined role of Validation Responsible and Operational Responsible to join our exciting new project . Apply now and join us!
The Position As a Validation Responsible, you will establish an overview of validation activities and priorities and ensure that our commissioning/qualification/validation documentation complies with Good Manufacturing Practices (GMP). This position will involve overseeing validation activities as well as ensuring operational efficiency within our project organization. Your primary responsibilities will be:

E xecuting documentation and procedures to support standardization efforts.

Developing and executing validation protocols and reports.

Ensuring alignment of documents and templates with NN validation process, from Science- and Risk-based approach to validation.

Ensuring compliance with industry standards and regulations.

Driving the implementation of documentation standards across our projects.

Training other colleagues in different quality standards used in the project.

You will also be responsible for communicating efficiently with stakeholders at all levels to ensure alignment and transparency and c ollaborating with cross-functional teams to streamline processes and workflows. The position as validation responsible can give opportunity to become area specialist, based on the experience of the candidate. You will be working from both Høje Taastrup and Odense. Qualifications To succeed in this position, we expect you to have:

An academic degree in a relevant field e.g., engineering, pharmaceutical sciences, or related disciplines

5+ years of experience of validation and commissioning / qualification / validation from a pharmaceutical company.

Excellent communication skills with experience of working cross functionally and building relations with stakeholders at all organizational levels.

Full proficiency in written and spoken English. Danish will be advantageous.

On a personal level, you bring a strong quality mindset and the ability to enforce it in a pragmatic way. You are self-driven and independent with a high sense of responsibility whilst enjoying working in a dynamic environment. Among your capabilities you show a proven ability to set direction as you are structured, detail-oriented, curious, good at planning and able to challenge. You have strong communication skills and thrive on engaging with people and building relationships, which includes the capability to manage various stakeholders effectively. About the department [xxxxx] is significantly increasing its manufacturing capacity across all areas to serve more patients in the coming years.  Our department is working to expand the capacity of our Biotech and Rare Disease production. 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 to serve more people living with serious chronic diseases including rare diseases.  Our new organization has just started its growth journey, and this is a unique chance to be part of a start-up environment within a large multinational organisation. In the coming period, a wide range of jobs will be posted covering a multitude of fields such as supply chain, engineering, operations, project management, people management, and business administration.  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 organisation. 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 at BRD, [xxxxx] Biotech & Rare Disease (BRD) is part of Novo Nordisk 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 3400 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.
Deadline  2 June 2024. We will process applications as we receive them, so please do not hesitate 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 your motivation to apply in your 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.