JOB SUMMARY:

The Validation Specialist supports the manufacturing team by performing process valuations on new and current manufacturing processes. This position reports to the Senior Director of Manufacturing.

MAJOR RESPONSIBILITIES:

• Conduct validation, temperature mapping, and calibration activities
• Measure instruments, software performance and machine performance to determine operating as defined and required
• Establish and maintain methods to control the biomanufacturing processes and develop effective ways to monitor product performance, and analyze data
• Generate, execute and review qualification and validation studies according to approved protocols and SOPs (Standard Operating Procedures)
• Write protocol documents and reports to show how each biomanufacturing system, piece of equipment, method, software or process is validated
• Analyze the results of testing and determine their acce...