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 REQUIREMENTS

Education and Experience

• High School Diploma, Bachelor’s or advanced degree in life sciences or related discipline, or equivalent education and experience.
• High school diploma with 3 or more years of experience in the pharmaceutical or biotech industry
• Bachelor’s degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.

Knowledge, Skills and Abilities:

• cGMP manufacturing for biological products is preferred.
• Fundamental knowledge of current biologics regulations and cGMP for drug substance operation.
• Proficient with Microsoft Word and Excel.
• Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
• Demonstrated ability to follow and document activities in written procedures and/or logbooks.
• Detail oriented, strong team player.
• Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.

• 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.