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Career
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Jacob Kaae Andersen

CQV specialist

Aseptic production | Efficient | Qualification & Validation

Summary

Jacob has a master’s degree in engineering and is a self-driven profile with the ability to support your engineering needs. Jacob comes with +15 years of experience from the pharmaceutical industry and has been a key player on several projects. Besides actual experience working on projects, Jacob has taken courses in project management and communication at DTU.

Jacob has experience in qualification of equipment and has facilitated the first GMP runs of new processes. Another of Jacob’s core competencies is qualification of cleanrooms including design review, HVAC and utility qualification.

Jacob has an all-round Q-profile and has experience in environmental monitoring and QC, and vast experience in elaboration of GMP documentation such as change control, risk assessment (FMEA) and work instructions.

Special Competences

  • Qualification & Risk assessment and qualification of equipment and cleanrooms
  • Aseptic production Knowledge of guidelines and understanding of aseptic production
  • Validation of processes and methods Aseptic production Knowledge of guidelines and understanding of aseptic production
  • Efficient Focused and good at getting things done

Project Experience

  • Wash & sterilization
    Qualification of bag sealers, implementation of monitoring plan for CIP and COP processes, deviation handling, change controls and WIN/SOP.
    Bavarian Nordic – May 2023 – ongoing
  • Utility qualification
    Work package owner for utility. Project with the aim of getting new facility ready for production. Task performed IQ/OQ of pure steam system and elaboration of PQ protocols for water systems.
    Xellia, Denmark – 2022–April 2023
  • Qualification of cleanroom
    Qualification of class 8 ISO cleanroom. Rolle includes providing IQ, OQ and PQ protocols/reports.
    ConvaTec, Denmark – 2022-Jan 2023
  • Implementation of bioreactor
    line Participating on project team that implemented a new bioreactor line in a company that did not have prior experience with bioreactor technology. The tasks included qualification, change control/request and SOP writing. Successful production of technical batches and first GMP runs.
    Bavarian Nordic, Denmark – 2020-2022
  • Decommissioning of production line
    Decommissioning of a small-scale filling line.
    Bavarian Nordic, Denmark – 2019
  • VHP decontamination validation
    Improving the set-up for VHP decontamination of production rooms and validation of the decontamination process.
    Bavarian Nordic, Denmark – 2016-2018

Other Relevant Experience

  • QC chemist
    Validation of analytical equipment, OOS and deviation handling
    Novo Nordisk, Denmark – 2010-2013
  • QC chemist
    Transfer of analysis from QC lab in Denmark to production site in Poland and Germany
    Nycomed, Denmark – 2009-2010
  • Chemist
    Filling Line, Validation of autoclave load and Validation of HVAC
    Novo Nordisk, Denmark – 2007-2008
  • Academic employee
    Vaccine production, change control/request and deviation handling
    Statens Serum Institut, Denmark – 2005-2007

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