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, records and equipment. Records data, logs activities and monitors processes. Achieves and maintains proficiency through training.
Qualifications:
The successful candidate will have a high school diploma. Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline or its equivalent is desired but not required. Prior job related experience required along with demonstrated mechanical aptitude.
Familiarity with general chemistry, mathematics, microbiology and cGMP clean room operations is a plus. the nature of the position demands keen attention to detail. Prior experience following and documenting written instructions is required.
Committed team player prepared to work in and embrace a team based culture.
Biologics Process Operator • East Syracuse, NY
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