Manufacturing Technician

Job Title:
Manufacturing Technician

Job Description

Provide manufacturing operations support, including the formulation and aseptic filling of cryopreservation media, cell culture media, and cell culture supplements. Execute and maintain documentation related to manufacturing procedures, ensuring compliance with applicable regulations and industry standards such as FDA 21

CFR, cGMP, and ISO
13485.

• Support all technical writing requirements for manufacturing and operations.
• Author and revise manufacturing batch records, SOPs, work instructions, validation/qualification protocols, forms, logbooks, technical reports, CAPAs, change controls, and any other applicable documents.
• Formulate, fill, and finish manufactured products, including cryopreservation media, cell culture media, and supplements.
• Perform aseptic processes in a controlled or cleanroom environment.
• Conduct in-process testing of products using general laboratory equipment and instrumentation.
• Utilize formulas and work instructions to monitor the production process.
• Perform experiments associated with development, improvement, and scaling up or optimization of manufacturing and development processes.
• Troubleshoot issues related to equipment and process development or production, including data analysis and internal record-keeping.
• Perform Environmental Monitoring activities as required.
• Maintain current knowledge of developments in product recovery and purification processes.
• Evaluate, troubleshoot, and solve routine problems, interpreting data based on knowledge and experience.