Reagent Bulk & Fill Technician IV

Responsibilities Lead manufacturing run activities including all applicable pre-production and post-production tasks Provide leadership and guidance to manufacturing associates Focus on fill/finish manufacturing Guide and lead the work of department associates executing daily operations Ensure production operations are conducted in compliance with policies, regulatory (GMP, FDA, ISO) and safety requirements Coordinate pre-production checks and activities Troubleshoot and resolve applicable technical issues Coordinate and execute applicable analytical testing activities Assist with batch record review and corrections Manage investigations and corrective/preventative actions Foster positive teamwork environment Requirements At least a Bachelors in biological or physical sciences At least 6 years of experience in the biotechnology/medical device industry At least 5 years of experience supporting a GMP environment Must have a thorough knowledge of cGMPs Computer skills are required (Word, Excel, Outlook) SAP, ATLAS, and TrackWise based system knowledge a plus Strong technical knowledge in commercial Purification and separation techniques Strong troubleshooting abilities Strong interpersonal and cross functional team building skills Must have experience supporting and/or leading deviation investigations #J-18808-Ljbffr Jobtailor