Aseptic Manufacturing Specialist

Job Description
REPORT TO: Manufacturing Manager


Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques, procedures and criteria. Able to summarize findings and prepare or assist in the preparation of reports, documents, records, etc., for assigned tasks. Other responsibilities include assist in monitoring, troubleshooting, maintaining and validation of equipment required for related manufacturing operations including support systems, as applicable.

Familiar with related GMP procedures and requirements, as directly related to the position.

Ensure that appropriate procedures and processes are utilized without unauthorized modifications.

Review all specifications, criteria, etc., and ensure all specified materials, equipment, and processes meet the required guidelines and/or industry standards.

Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation.

Perform and or assist in validation of protocols for specific projects in compliance with IQ/OQ/PQ requirements and industry guidelines.

Assist in developing SOPís for all manufacturing related activities as required for a GMP compliant Fill/Finish operation.

Develop written preventative maintenance program for all manufacturing related equipment and systems.

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 level of experience.

Ability to calibrate, maintain and trouble-shoot various equipment as required for the manufacturing operations.

Perform various manufacturing duties and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOPís

Written and oral skills at a level commensurate for interaction with staff, vendors and clients as necessary.

Familiarity with computers and software programs utilized for the generation of data and associated reports as related to manufacturing operations.

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.


PYRAMID Laboratories, Inc.

Job Code

State or Province


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