Our client is actively seeking a Manufacturing Process Development Consultant for a year long project. Currently the manager is overworked and needs an extra pair of hands to help his group, only has 2 FTEs (one 1st shift, one 2nd shift). Asking for this person to be flexible and may have to help out on 2nd shift 10% of the time, but mainly it will be 1st shift work. This resource will be working on manufacturing and process development activities with the MS&T group, supporting execution of continuous process improvement through product investigations/troubleshooting root cause analysis for investigations. Wants to see experience with bioreactors, cleaning validation IQ/OQ/PQ (no prior execution work necessary), laser cutting, some project management, strong technical writing experience for cGMP manufacturing processes, deviations/CAPAs, and batch record review.
Manufacturing Shop Floor experience
Education: Required, Bachelor’s Degree or Engineering and 5-6 years of direct industry experience
MA: Manufacturing / Process Development Engineer (232390)