Summary

The primary role of the candidate is working on assignments that train for proficiency in the operation of primary production equipment including adherence to detailed procedures and batch records ensuring compliance with cGMP and safety requirements. Work is performed in a team environment within a medium-scale biologics manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE). Additional gowning through the processing areas and maintaining clean hygiene is a requirement to control established environmental specifications.

Prepares process buffers and reagents. Cleans equipment and maintain area in clean and orderly fashion. Recognizes and reports safety, maintenance and operational variances to area management. Communicates status of operations to area management in a timely manner. Follows detailed SOPs and batch records. Ensures compliance with cGMP and safety requirements. Maintains files...