Jacob Kaae Andersen

Senior/Specialist Consultant

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 upstream 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
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

Implementation of grade C cleanroom
Work package owner for facility and utility. Project with the aim of getting new facility ready for production. Rolle includes coordinating repair and performing qualification of cleanroom including PQ of utilities.
Xellia, Denmark – 2022–ongoing