POSITION TITLE: Manufacturing Technician
REPORT TO: Director of Manufacturing
Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques and procedures. Able to assist in the preparation of reports, records, etc., for assigned tasks.
- Familiar with related GMP procedures and requirements, as directly related to the position.
- Ensure that appropriate procedures and processes are utilized without unauthorized modifications.
- Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation.
- Perform aseptic filling for drug products in vials and pre-filled syringes.
- Perform sanitization of clean rooms, and sterilization and depyrogenation of manufacturing equipment.
- Perform all duties and manufacturing activities according to the applicable guidelines, i.e. FDA, GMP, ICH, etc.
- Ability to problem solve and assist in technical decision-making commensurate with the level of experience.
- Perform various manufacturing duties and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOP’s.
- Performs other related duties and responsibilities as assigned.
- Minimum (1) year of experience in a GMP environment. No degree required.
- Must have experience working in Grade A environment with filling machines.
- Demonstrated ability to work under general supervision; exhibit skills to coordinate projects on various levels.
- Excellent oral and written communication skills are required.
To apply for this position, please email your resume with cover letter to firstname.lastname@example.org .