Senior Validation Engineer
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Nordsjælland
Are you an expert who is looking for a global position where you can drive Cleaning & Sterilization processes equipment design and validation standards globally? Do you feel ready to take on challenges? Would you like to have fun during your working days? Then you are the Senior Validation Engineer we are looking for. Apply now for a life-changing career!
The Position As a Senior Validation Engineer, you will be a key player in defining the future global standard for equipment & processes for Cleaning in Place/Sterilization in Place (CIP/SIP) and associated validation approach. We are working in collaboration with a wide network of stakeholders on a local and global level. This will include the CIPSIP Work Package Owner (WPO), Project Managers, Specialists, our Central Manufacturing Development Team, and local sites stakeholders. Together with sites all around the world and suppliers of equipment and our engineering partners, we develop and validate the best possible solutions. While being stationed in Lyngby, you will travel to our global sites, including sites based in Denmark, France, US, Brazil, and China. 20% travel is expected for the position. The main tasks will be to:
• Drive the development and validation for the CIPSIP equipment.
• Collaborate design development with suppliers going into oversight to ensure the solution is build according to the design.
• Be the key player during design qualifications, FAT - SAT - Qualification activities.
• Ensure the development of qualification approach that will enable a streamlined implementation of the standard solution. Qualifications To succeed in this role, you have:
• A bachelor’s or master’s degree in engineering, chemistry, biotechnology, pharmacy, natural science or similar.
• Hands-on experience with project qualification, and validation activities.
• Solid experience in project execution or validation experience within Aseptic process, pharmaceutical industry, or similar areas. Cleaning & Sterilisation process experience is considered a plus.
• Experience in GMP in the pharmaceutical, biotechnology or similar industry.
• Excellent stakeholder management skills and experience working cross-functionally with various cultures, job functions, and experience levels. For this position, it is required to be fluent in spoken and written English. As you will be working globally with the Danish sites, US, Brazil, France and China, language skills within these areas would be considered a plus. On a personal level, you are focused on quality, deliverables and have the drive to create new solutions. Forward-thinking and visionary outlook allow you to anticipate future trends and promote process optimization and digitalization. Having global citizen mentality and being naturally inclined to working with colleagues to deliver exceptional outcomes that exceed expectations are foundations we like to build on in the team. Excellent communication skills and the ability to build trusted relationships cross functionally and globally are key to succeed in this role. About the department Technology Standards is a department in the newly created area of Fill & Finish Expansions. Fill & Finish Expansions is anchored in Product Supply, which globally accounts for +19,000 of ’s +50,000 employees. The responsibility of Fill & Finish Expansions is to plan and execute the establishment of new aseptic filling capacity across the global manufacturing network. Including BioTech and Rare Diseases (BRD) and Injectable Finished Products (IFP) for new filling platforms while ensuring harmonisation and global standards. Across the different roles there is a distinct global aspect as the end goal is a global standard and best practice, and working with multiple sites, cultures and traditions will be a key element. Working at We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at life means many things – from building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work.
Contact For further information, please contact Senior Manager Formulation and W&S Bo Hove Vanting Andersen at +or Senior Project Manager Jia Gu at +. Deadline 19 May 2024. 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 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.
The Position As a Senior Validation Engineer, you will be a key player in defining the future global standard for equipment & processes for Cleaning in Place/Sterilization in Place (CIP/SIP) and associated validation approach. We are working in collaboration with a wide network of stakeholders on a local and global level. This will include the CIPSIP Work Package Owner (WPO), Project Managers, Specialists, our Central Manufacturing Development Team, and local sites stakeholders. Together with sites all around the world and suppliers of equipment and our engineering partners, we develop and validate the best possible solutions. While being stationed in Lyngby, you will travel to our global sites, including sites based in Denmark, France, US, Brazil, and China. 20% travel is expected for the position. The main tasks will be to:
• Drive the development and validation for the CIPSIP equipment.
• Collaborate design development with suppliers going into oversight to ensure the solution is build according to the design.
• Be the key player during design qualifications, FAT - SAT - Qualification activities.
• Ensure the development of qualification approach that will enable a streamlined implementation of the standard solution. Qualifications To succeed in this role, you have:
• A bachelor’s or master’s degree in engineering, chemistry, biotechnology, pharmacy, natural science or similar.
• Hands-on experience with project qualification, and validation activities.
• Solid experience in project execution or validation experience within Aseptic process, pharmaceutical industry, or similar areas. Cleaning & Sterilisation process experience is considered a plus.
• Experience in GMP in the pharmaceutical, biotechnology or similar industry.
• Excellent stakeholder management skills and experience working cross-functionally with various cultures, job functions, and experience levels. For this position, it is required to be fluent in spoken and written English. As you will be working globally with the Danish sites, US, Brazil, France and China, language skills within these areas would be considered a plus. On a personal level, you are focused on quality, deliverables and have the drive to create new solutions. Forward-thinking and visionary outlook allow you to anticipate future trends and promote process optimization and digitalization. Having global citizen mentality and being naturally inclined to working with colleagues to deliver exceptional outcomes that exceed expectations are foundations we like to build on in the team. Excellent communication skills and the ability to build trusted relationships cross functionally and globally are key to succeed in this role. About the department Technology Standards is a department in the newly created area of Fill & Finish Expansions. Fill & Finish Expansions is anchored in Product Supply, which globally accounts for +19,000 of ’s +50,000 employees. The responsibility of Fill & Finish Expansions is to plan and execute the establishment of new aseptic filling capacity across the global manufacturing network. Including BioTech and Rare Diseases (BRD) and Injectable Finished Products (IFP) for new filling platforms while ensuring harmonisation and global standards. Across the different roles there is a distinct global aspect as the end goal is a global standard and best practice, and working with multiple sites, cultures and traditions will be a key element. Working at We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at life means many things – from building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work.
Contact For further information, please contact Senior Manager Formulation and W&S Bo Hove Vanting Andersen at +or Senior Project Manager Jia Gu at +. Deadline 19 May 2024. 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 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.
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Nordsjælland
Jobbet er oprettet på vores service den 28.3.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Projektleder
- Nordsjælland
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| Dato | Alle jobs som projektledere |
|---|---|
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