Technical Services Engineer-Scientist III

 Technical Services Engineer - Scientist III for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Lead complex investigations involv. cross-funct. depts, discuss Fishbone anlys, perf add’l investigative studies, create investigation rpts, + implement CAPA as necessary. Work on new prod launches, alt API/Excipient qual, scale up/down, submiss. batches, + tech transfer pjcts. Serve as TS lead on tech svcs pjcts (proc. improv., cleaning validation, proc. troubleshooting, alt mat’l, eng’ring + reg Qs, + APR/CPV discs.), incl coord activities + mtngs across depts + prep mtng mins. Prep training mat’l for periodic training for cGMP + compl. enhncmnt, + training Jr TS personnel + floor op’rs. Assist mfg + pkg to troubleshoot, problem solve, + analy prod impact. Own + update dept policy + SOP doc. Own + maint. site cleaning validation prog in full compliance. Genr. study rpts + tech justification rpts for regul. filing to sup. CBE-0/30 or PAS, new prod filing + rel deficiency resp. Serve as SME for TS-rel. activities during FDA, DEA, + other regul. + customer audits. Occasional eve & wknd hrs. May undergo background checks and drug screening.  

Must have Bach’s in Chem, Pharm, Biology, rel Eng’ring or other rel field and 5 yrs rel exp in GMP environment in pharmaceutical industry, working within a technical services OR validation department. Also requires skills (5 yrs exp) in: completing all aspects of validation activities, including writing protocols and reports; investigating process deviations, creating investigation reports, and implementing CAPA in GMP pharmaceutical manufacturing and laboratory environment; revising and creating GMP master batch records, official forms, and SOPs; preparing GMP change controls; working on TS projects with minimal direction; compiling CQA data on commercial batches for annual product review and for continued process verification activities; and generating placebo batch records and performing PQ studies for Equipment Qualifications (EQ), and teaming up with EQ Engineers for EQ activities. Alternatively, may have a Masters in Chem, Pharm, Biology, rel Eng’ring or other rel field and 2 yrs rel exp in GMP environment in pharmaceutical industry, working within a technical services OR validation department. Also requires skills (2 yrs exp) in: completing all aspects of validation activities, including writing protocols and reports; investigating process deviations, creating investigation reports, and implementing CAPA in GMP pharmaceutical manufacturing and laboratory environment; revising and creating GMP master batch records, official forms, and SOPs; preparing GMP change controls; working on TS projects with minimal direction; compiling CQA data on commercial batches for annual product review and for continued process verification activities; and generating placebo batch records and performing PQ studies for Equipment Qualifications (EQ), and teaming up with EQ Engineers for EQ activities. Any suitable combination of education, training, or experience is acceptable.