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 acceptability against predetermined criteria

Adhere to strict documentation, reviews and approvals. Investigate and troubleshoot problems and determine solutions or recommendations for changes and improvements, including expanding facilities and upgradi...