Chemical Development Engineer - Bilingual German

 Responsibilities:Working with CMO as a key contributor to develop information for:

Scale-Up program  of an APIAssembling available information  on existing equipment and planned changes from CMOWorking with management in reviewing and communicating  available information and scale up plans.Make recommendations on feasibility of  or alternatives to plans Documenting plans and process to final planParticipate in technical transfer  process to CMO of critical process parameters  and possible process changes

Key contributor in writing process Scale up reports and in assisting in the Technical transfer and  pharmaceutical development reports.

 Key resource to monitor and track Process performance data during campaigns  at site  Expected to spend significant time at site directly monitoring production Prior API multistep chemical synthesis scaleup experience (preference given to scaleup  with a CMO)Prior process engineer experience, minimally 6-10 years. Prefer  exposure to large variety of processes, as might be obtained in pilot facilities and or large production facilitiesExperience with basic unit operations, such as chemical reaction, hydrogenation, distillation, crystallization, centrifugation, and drying.Good understanding of the operations and mechanical details of chemical equipment, such as glass-lined reactors, heat exchangers, agitators, pumps, centrifuge, scrubber, dryer, etc.Demonstrated skills in writing SOP?s, Batch records and engineering studies . Demonstrated skills in assembling,as a key contributor, technical reports for scale up, tech transfer and/or pharmaceutical process development reports.  Familiar with equipment and process validation in pharmaceuticals

Qualifications:Candidate must have strong language skills in German, including ability to read and understand technical documents  and drawings in GermanGood verbal and written communication skills in English.Minimum of Bachelors Chemical  Engineer Pharmaceutical cGMP training, familiar with ICHQ7A requirements, safety and environmental regulations, necessary for the manufacture of pharmaceuticals.Knowledge of Microsoft Word/Excel/Project is also required.