Aseptic Manufacturing Specialist

POSITION TITLE: Aseptic Manufacturing Specialist

REPORT TO: Manufacturing Manager



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.  Other responsibilities include monitoring, troubleshooting, maintaining and validation of equipment required for related manufacturing operations including support systems, as applicable.


  1. Familiar with related GMP procedures and requirements, as directly related to the position.
  2. Ensure that appropriate procedures and processes are utilized without unauthorized modifications.
  3. Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation.
  4. Perform sanitization of clean rooms, and sterilization and depyrogenation of manufacturing equipment.
  5. Perform and or assist in validation of protocols for specific projects in compliance with IQ/OQ/PQ requirements and industry guidelines.
  6. Perform all duties and manufacturing activities according to the applicable guidelines, i.e. FDA, GMP, ICH, etc.
  7. Ability to problem solve and assist in technical decision-making commensurate with level of experience.
  8. Perform various manufacturing duties and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOP’s.
  9. Familiarity with computers and software programs utilized for the generation of data and associated reports as related to manufacturing operations.
  10. Performs other related duties and responsibilities as assigned.


Minimum (1) year of experience in a GMP/GLP environment.  No degree required.

Demonstrated competence in manufacturing related activities through education and experience.

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 .