Operational Readiness and Process Specialist for an aseptic production area

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Operational Readiness and Process Specialist for an aseptic production area
Production

Xellia Pharmaceuticals is looking for an experienced Operational Readiness and Process Specialist for an aseptic production area in a newly established project team. The team is responsible for implementing a new aseptic process line in a newly established facility for API bulk production at the Copenhagen site. The new production facility will ensure the future of aseptic API production at Xellia Pharmaceuticals. The facility and utility have already been built and the equipment is in the process of being qualified, which will subsequently be followed by process validation. In 2025, the production facility and process line will become a part of the commercial routine production, where this position will transfer into daily routine production support.

Sterility Assurance Team
The sterility assurance team is a newly established team and will count approximately 15 people towards the end of 2022. The team will consist of various specialists and project operators, where some specialists will have track lead responsibility. The team is responsible for the qualification and validation activities including the establishing of the environmental monitoring program and preparation for operational readiness for commercial production including the integration into existing department.

Your role
You will have the responsibility of ensuring that the production facility and process line are ready for qualification (PQ), validation, and later commercial production including integration. You will work in close collaboration with track leads for operational readiness and process.
Your primary tasks and responsibilities:

  • Responsible for design, preparation, and execution including documentation packages:
    • Performance qualification (PQ)
    • Smoke studies
    • Process simulation
    • Process validation (PV)
    • Stability studies

  • Define sampling program
  • Define and describe man and material flow
  • Ensure batch documentation is ready
  • Create and write SOPs, work instructions and logbooks
  • Create training setup for operators and specialist
  • Ensure alignment with environmental monitoring program, calibration and maintenance program
  • Responsible for change controls and deviations

The position will in the first two years primarily be project related. As the project progresses, the position will change towards more operational and daily routine. The transformation will happen gradually as the project gets closer to be integrated with the existing production. The work takes place in close collaboration with the rest of the project team, as well as the Final Handling department and Quality departments. Good communication skills are important to succeed in this position, as you will have collaborating partners across the entire organization due to the project’s strategic importance.
The position will have a good distribution between desk work, such as writing and preparing of documentation, and hands-on experience and testing activities in the actual facility.

The position will have direct report to the Team Leader of Sterility Assurance.

Our expectations
You have an educational background as an engineer, cand.scient. or similar, with minimum two years of experience in the pharmaceutical industry. Preferably, you have knowledge about production in classified areas. It will be an advantage if you are familiar with project management tools, and you should have an analytic and systematic approach to your work. You should be fluent in both English and Danish.
You are known for your willingness to cooperate, a good mood, and an openminded approach to both colleagues and tasks. In addition, you are a strong communicator with a structured mindset and know the importance of finalizing tasks.

We offer
An exciting and challenging position in a company in continuous development. You will work in an international environment with good colleagues and a high professional level. The position is intended for a key role in the team with opportunity to provide your personal touch. Xellia will contribute to your development through e.g. appraisals conversation with your immediate manager, on-the-job training, and the opportunity to participate in relevant courses.
We offer competitive salary package with potential bonus, 12.5% company paid pension of base salary and health insurance.

Additional information
If you have questions or want to know more about the position, please contact Team Leader of Sterility Assurance, API Manufacturing CPH, Michael Lee-Pedersen at +45 31 92 83 87.

Please, apply the position via the link before 22 April 2022. Starting date is as soon as possible, and we will conduct interviews on a continual basis, so do not hesitate to apply today!

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
Connect with us on LinkedIn


Information og data

Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i København

Jobbet er oprettet på vores service den 21.3.2022, men kan have været deaktiveret og genaktiveret igen.

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