Shannon Doyle, Senior Automation Engineer
With a Bachelor’s of Science in Engineering from Purdue University, Shannon has 14 years of field experience in cGMP pharmaceutical facilities as a Technical Writer and Validation Engineer. Customers describe her as the perfect combination of diligence and grace.
• FDA and Current Good Manufacturing Practices (cGMP)
• Principals of cGMP Equipment Validation and Qualification
• Reverse Engineering of existing systems that lack sequences of operation or other documentation
• Development and execution of cGMP Validation documents for equipment and facilities, including IQ/OQ/PQ protocols, final reports, and associated documentation
• Creating lifecycle documents like User Requirements Specifications (URS), as well as Impact Assessments and Risk Management strategy documents
• Coordination of Equipment Standards Committees, including rewriting and reorganizing technical information, summarizing team objectives and meeting notes, and handling variance requests