Environmental Monitoring Specialist with experience in aseptic production and clean room
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Production
Xellia is looking for an Environmental Monitoring Specialist with experience in aseptic production and clean room for a newly started project team. The team is responsible for implementing a brand new production facility with associated process line for aseptic handling of API Bulk on our site in Copenhagen. The new facility will ensure Xellia’s future production of aseptically produced API. The production facility has been built, and the equipment is in the process of being qualified and will afterwards be process validated. In the summer of 2025, the production facility and process line will transfer to commercial production.
It can become your responsibility to help design and implement the EM program for the new production facility and process line. You will help ensure that the production facility and process line is ready for qualification, validation and commercial production later on. You will be working as both Specialist and Track Lead for the EM track in the project.
The position
In this position, your primary tasks will be to:
- help design and implement the EM program
- be Track Lead for the EM track, incl. being responsible for the project plan, document overview, facilitation, etc.
- ensure that the facility and the production line is ready for PQ/PV
- ensure that the facility and the production line is ready for commercial production
- run the risk assessment in relation to the EM program
- help define and implement the contamination control strategy.
During the first two years, the position will focus primarily on project-related work, but it will, as the project progresses and the new line is integrated into the existing production, be more oriented toward operation. The work will be conducted in close collaboration with the rest of the project team, as well as the Quality department and the Engineering department. As the project is strategically important, there will also be collaboration across both the local and global organization, which means that great communication skills are important to succeed in this position.
The position will include some amount of documentation and desk work, but you will also have to participate in the test and monitoring activities, therefore, you must be ready to roll up your sleeves and go down and check the equipment.
This position has direct reference to the Team Leader in Sterility Assurance.
The team
The Sterility Assurance team is a newly established team which will, by the end of 2022, consists of approx. 15 employees. The team will consist of Specialists and Project Operators, and some selected Specialists will also have Track Lead responsibility. The team will be responsible for most of the project’s aspects, from equipment qualification, process validation to operational implementation into the existing operations, as well as the EM program and environmental monitoring.
Your profile
We would prefer someone with an educational background as an engineer, Master of Science or similar and with at least two years of experience from the pharmaceutical industry. Experience with environmental monitoring is a requirement, but candidates with experience in clean room and aseptic process handling will be preferred. It is an advantage if you have knowledge of any project manager tools. As our new colleague, we expect you to have an analytical and systematical approach to your work; preferably with experience within qualification and validation of equipment and processes.
We would like you to be known for your collaboration skills, great spirits and a welcoming approach to both colleagues and work tasks. Moreover, we expect you to be a strong communicator, to be structured and to know the importance of following the matter through.
We offer
You will get an exciting and challenging position in an expanding organization. You will be working in an international environment in close collaboration with great and competent colleagues. The position is intended to have a key role in the new team, and you will have the opportunity to leave your personal mark on the team. Xellia wants to contribute to your development via development interviews with your immediate superior, on-the-job training, and provide you with the possibility to participate in relevant courses and the alike.
We offer a competitive salary package, including bonus opportunity, a company-paid pension scheme of 12.5% of the gross salary and health insurance.
Date for application and information
Send your application as soon as possible and no later than 1 August 2022. Interviews will be held on an ongoing basis. If you have questions or need further information, please contact Team Leader, Sterility Assurance Project, Tobias Rybner on +45 23 83 28 51.
Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
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Information og data
Denne ledige stilling har jobtypen "Bygningsarbejder", og befinder sig i kategorien "Industri, håndværk og teknik".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 26.1.2022, men kan have været deaktiveret og genaktiveret igen.
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