Manufacturing Technician I, Production Support

Bora Biologics; San Diego (CA); On-site; USD 56,000 - 75,000; Full time

Job summary

Bora Biologics in San Diego seeks a Manufacturing Technician, Production Support to perform routine manufacturing activities in GMP areas, solution preparation, dispensing raw materials, and bioprocessing support, including autoclave operation.

Under supervision, you will follow SOPs, WI, and MBRs, draft and revise documents, and maintain detailed logs. Flexible shift schedules and overtime may be required.

Qualifications

• cGMP manufacturing for biologics is expected.
• Fundamental knowledge of biologics regulations and cGMP for drug substance operation.
• Proficient with Microsoft Word and Excel.
• Ability to work with pressurized systems, steam, and corrosive chemicals with safety precautions.
• Detail-oriented and able to follow written procedures and logbooks.

Responsibilities

• Perform GMP manufacturing activities in assigned areas.
• Perform routine cleaning activities in GMP manufacturing areas
• Follow SOPs, cGMPs, safety guidelines during manufacturing 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.
• Manual cleaning and sterilization of parts and components.
• Maintain detailed process-related documentation of equipment logs and batch records.
• Draft and revise SOPs and batch records.
• Address production issues and report compliance concerns to supervisor.

Skills

cGMP knowledge

Biologics knowledge

Documentation

Safety compliance

Education

Bachelor's degree in life sciences

High School Diploma + 3+ years pharma/biotech experience

Tools

Bioprocess equipment

Job description

Description

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.

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.
• Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.