POSITION SUMMARY:

The Temp Manufacturing Technician performs various manufacturing related activities for a GMP compliant Fill/Finish operation, applying standard practices, techniques, and procedures. The Technician monitors, troubleshoots, maintains and supports validation of the equipment required for the manufacturing operations including support systems, as applicable.

PRINCIPAL DUTIES:

• Perform various routine manufacturing tasks under the direction of internal SOPs and Batch Records.
• Prepare material components for manufacturing operations.
• 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.
• Document steps clearly and completely in production batch records, logbooks and other controlled forms
• Perform basic arithmetic and algebraic computation.
• Maintain cleanliness of areas and equipment.
• Assist and/or perform sterile filtration activities.
• Monitor equipment and process parameters to ensure optimal production performance.
• Document observations and report any discrepancies or issues to the supervisor.
• Complete production and quality records accurately in a timely manner.
• Collaborate with team members and supervisors to optimize production processes and workflows.
• Participate in team meetings and training sessions to enhance skills and knowledge.
• Collaborate in continuous improvement activities, escalate deficiencies in the process and documentation.

• 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).
• Familiar with related GMP procedures and requirements, as directly related to the position.
• Familiar with computers and software programs utilized for the generation of data and associated reports related to manufacturing operations.
• Available to work other shifts when necessary.
• Experience: A minimum of 2 years of relevant experience