Validation Engineering Associate

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 fac...