Manufacturing Technician I, Production Support

Job Description

Job Description

Description : SUMMARY

Under supervision, the Manufacturing Technician, Production Support, will perform routine manufacturing activities in GMP manufacturing areas, solution preparation, dispensing raw material, bioprocessing support and autoclave operation. Operations will be performed according to Standard Operating Procedures (SOP), Work Instructions (WI) and Master Batch Records (MBR). Perform manufacturing steps, execute routine MBRs, and revise documents such as MBRs and SOPs as needed. Flexible shift schedules and overtime may be required.

JOB RESPONSIBILITIES

• Perform GMP manufacturing activities in assigned areas.
• Perform routine cleaning activities in GMP manufacturing areas
• Follow Standard Operating Procedures (SOPs), cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality products.
• Set-up, operate, maintain and clean bioprocessing equipment.
• Demonstrate good aseptic technique.
• Perform dispensing raw material.
• Basic troubleshooting of bioprocess equipment.
• Perform manual cleaning and sterilization of parts and components.
• Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices.
• Draft and revise SOPs and batch records.
• Address production issues and report any compliance related concerns to the supervisor.

JOB REQUIREMENTS

Education and Experience

Knowledge, Skills and Abilities :

Requirements :