Manufacturing Technician
The Manufacturing Technician will be required to work in a Clean Room environment. The Technician will perform Sterile Fill & Finish and is responsible for executing SOPs and batch records for aseptic drug manufacturing processes in a GMP environment Inclusive of performing environmental monitoring (viable and non-viable).
This position reports to Supervisor of Manufacturing. The individual must be able to follow written instructions and procedures and accurately document their work.
The individual will work directly with other members of the Operations team and with Quality Assurance.
Qualified candidates will have worked within an Aseptic Processing Facility and can leverage their previous experience to deliver world class quality for our clients and organization.
Qualifications: BS degree and 3-5 years related experience in a GMP clean room environment. Experience with clean room gowning and Aseptic Processing. Ability to read, understand and accurately execute batch records. Ability to interpret technical instructions in diagram form. Ability to lift 50 pounds. Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves for up to 4 hours per day.
Responsibilities: Execute batch production records. Operate filling equipment. Perform filter integrity testing. Perform visual inspections of filled vials. Assist in maintenance of Clean Rooms and anteroom in an orderly state. Assist in maintaining stock of Clean Room and production supplies. Assist in validation of Clean Room facilities and equipment.
Participate in media fills. Assist in preparation of Master Batch Records, Assist in preparation of SOPs for Clean Room equipment and processes. Provide input during CAPA investigations of deviations, sterility failures, non-conforming materials, and complaints.
