Manufacturing Technician

POSITION SUMMARY:

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.

PRINCIPAL DUTIES:

• 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 sanitization of clean rooms, sterilization and depyrogenation of manufacturing equipment.
• Perform and or assist in validation of protocols for specific projects in compliance with IQ/OQ/PQ requirements and industry guidelines.
• Assist in developing SOPs for all manufacturing related activities as required for a GMP compliant Fill/Finish operation.
• 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 experienc
• Perform various manufacturing duties and initiate appropriate documentation as required including all forms, logs, batch records, etc., according to the applicable SOPs.
• Familiarity with computers and software programs utilized for the generation of data and associated reports as related to manufacturing operations.
• Available to work other shifts when necessary.
• Performs other related duties and responsibilities as assigned.

QUALIFICATIONS AND EXPERIENCE:

• Education: A Minimum of high school diploma or an associate degree in a related field.
• Skills: Key skills include proficiency in operating and maintaining manufacturing machinery, understanding of pharmaceutical production processes, attention to detail, problem solving abilities, and knowledge of Good Manufacturing Practices (GMP).
• Experience: A minimum of 2 years of relevant experience