We are recruiting, on behalf of our client, an experienced Cell culture Engineer with experience in biopharmaceutical and/or Biotech industries.
You have at least 6 years professional experience as a Cell culture engineer with expertise with CHO-cells, bioreactor culture and process development.
You will join an international biopharmaceutical industry with a worldwide exposure and directly contribute to the development of new therapies.
Join Modis Life Science to participate to the development of new therapies!
· Equipment Owner for the Main Cell Culture Area; containing 6x 20K and 3x 5K Bioreactors and associated process support equipment.
· Support the area from the end of detailed design to end of engineering runs of the first product introduction.
· Site point of contact and technical support for; Engineering design, Construction, CQV, Automation, Calibrations, MSAT, Plant engineering and operations. Engineering signoff on all lifecycle documents
· Minimum Bachelor in bio-engineering
· Min 8 years’ experience in a full-scale large molecule drug substance facility
· Min 5 years’ experience as an engineering package owner
· Has worked from design to commercial as a engineering package owner on a full scale startup project
· Detailed knowledge of CHO cell culture processes CIP and SIP design for upstream
· Upstream recipe design, Understanding all operational procedures Knowledge of DIN dimensional standards, typical piping specifications, and ASME-BPE Strong understanding of the design process on a large startup
· Strong understanding of the CQV lifecycle Understanding of tech transfer and MSAT process and process descriptions
· Used to working with vendors in support of site optimizations
· Proficient in Navisworks and 3d model reviews to support online and offline area
· Fluency in English required, German language is an asset