Michael Boyden Email & Phone Number

Promoted to Systems Validation Engineer to lead and coordinate process implementations of laboratory software systems and process improvements. Developed, performed, and reviewed dozens of software testing and validation plans to ensure they met or exceeded quality and regulatory standards (FDA, ISO, GxP). Created SOP’s and training documents for new and modified processes. Subject matter expert for multiple systems, processes, and laboratory testing platforms. Mentoring and development of 3… Show more Promoted to Systems Validation Engineer to lead and coordinate process implementations of laboratory software systems and process improvements. Developed, performed, and reviewed dozens of software testing and validation plans to ensure they met or exceeded quality and regulatory standards (FDA, ISO, GxP). Created SOP’s and training documents for new and modified processes. Subject matter expert for multiple systems, processes, and laboratory testing platforms. Mentoring and development of 3 team members Key Achievements:• Validation Team Leader for numerous implementations across multiple laboratory systems and processes including; Abbott STARLiMS®, Abbott A3600 Automation, Data Innovations® Instrument Manager™, and Haemonetics® Surround™, AcQuire™ • Subject matter expert for Abbott STARLiMS®• Completed all validations on or before scheduled project deadlines Show less

Promoted to business integration department as part of cross functional team tasked to analyze current laboratory processes for quality driven improvements including automation and system integrations. Performed user acceptance testing, system and process validation, risk assessments and assisted in gathering requirements/user needs. Key Achievements:• Validation and process implementation team lead for Phase 1 implementation of Abbott STARLiMS®• Core Project Team Member for Abbott… Show more Promoted to business integration department as part of cross functional team tasked to analyze current laboratory processes for quality driven improvements including automation and system integrations. Performed user acceptance testing, system and process validation, risk assessments and assisted in gathering requirements/user needs. Key Achievements:• Validation and process implementation team lead for Phase 1 implementation of Abbott STARLiMS®• Core Project Team Member for Abbott STARLiMS® laboratory information system• Lean Manufacturing Certification• Subject matter expert for multiple lab processes and systems. Show less

Responsible for infectious disease testing of human blood and plasma samples through operation of laboratory instruments and maintaining concurrent and accurate documentation utilizing established protocols and quality control checks. Promoted to Lab Technologist II and III gaining responsibilities which included testing using manual DNA extraction methods and PCR, DNA/RNA molecular beacon assays, and the training of new employees.Key Achievements:• Subject matter expert for Roche… Show more Responsible for infectious disease testing of human blood and plasma samples through operation of laboratory instruments and maintaining concurrent and accurate documentation utilizing established protocols and quality control checks. Promoted to Lab Technologist II and III gaining responsibilities which included testing using manual DNA extraction methods and PCR, DNA/RNA molecular beacon assays, and the training of new employees.Key Achievements:• Subject matter expert for Roche Cobas s201 testing platform and QualTex genetic testing laboratory processes• Proven ability to troubleshoot equipment malfunctions, testing discrepancies, and technical problems Show less