Operations Specialist

Location: Gaithersburg, MD
Date Posted: 01-29-2018
Hours: 3pm to 11pm  2nd shift

The technician is responsible for the operation of equipment according to established Standard Operating Procedures and Master Production Records for the manufacture of therapeutic proteins and vaccines in accordance with Current Good Manufacturing Practices (cGMP’s). 

Qualifications 

Bachelor’s degree in the sciences and 0+ years relevant experience. 

Principal Duties 

• Operates production equipment such as bioreactors, centrifuges, filtration devices, chromatography equipment, washers, autoclaves, tanks. 
• Weighs and checks raw materials, assembles and cleans process equipment, monitors processes 
• Performs SIP, CIP and manual cleaning and sanitization of equipment 
• Demonstrates aseptic technique Completes production records 
• Maintains clean room environment to comply with regulatory requirements 
• Ensures a safe work environment in accordance with Medimmune’s standards 
• Basic understanding of cGMP documentation standards for SOP’s MPR and SPR’s 
• Adheres to Good Manufacturing Practices and standard operating procedures. 
• Regularly works on routine manufacturing assignments 
• Learning and executing basic troubleshooting techniques on equipment and process 
• Works under direct supervision 
• Receives instructions, as needed, on routine work and more detailed instructions on new assignments 
• Interacts regularly with co-workers, senior personnel and supervisor in dynamic and team environment. 

Support Services Group Specific Duties 

• Perform SIP, CIP and manual cleaning and sanitization of equipment 
• Preparation and filtration of production scale buffer and media solutions. 
• Operate area specific production equipment such as glass washers, autoclaves, fixed and portable stainless steel tanks, etc.
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