Roger Busey has over 20 years of experience in aseptic pharmaceutical manufacturing, including as a Senior/Lead Blow-Fill-Seal Technician at Mylan Specialty L.P. from 1997-2013. He has extensive experience in sterile manufacturing processes, quality inspections, equipment operation and maintenance, and training operators in a cGMP environment. Prior to Mylan, he served in the United States Air Force from 1983-1992 as a wideband communications specialist and sensor maintenance technician.

1. Roger Busey
Jacksonville, FL (707) 690-8477 infin0pwr@comcast.net
Summary
Qualified and experienced professional in the field of aseptic pharmaceutical manufacturing.
Work History
Mylan Specialty L.P. Napa CA 1993-July 2013
A specialty pharmaceutical company focused on the development, manufacturing, and marketing of prescription drug
products for the treatment of respiratory diseases, life-threatening allergic reactions, and psychiatric disorders.
Experience
Senior/Lead Blow-Fill-Seal Technician 1997-July 2013
Responsible for the sterile / aseptic manufacturing of nebulized pharmaceutical products in a FDA regulated aseptic
environment utilizing Blow Fill Seal Technology in accordance with Standard Operating Procedures.
• Performing lot change activities (Clean in Place, Sterilize in Place and machine set-up) to prepare BFS
machines for commercial activities and operating manufacturing equipment as defined by Manufacturing
Production Records.
• Bulk formulations (manual and automated) of batch sizes ranging from 500L to 4000L.
• Weighing and dispensing of active pharmaceutical ingredients.
• On-line / off-line filter integrity testing.
• In-Process Quality inspections for fill volume accuracy, vial weight specifications and cosmetic defects.
• Utilizing data of In-Process Inspections to identify potential negative trends to initiate troubleshooting
activities and assist with implementing corrective actions.
• Performing routine machine inspections to ensure manufacturing equipment and utilities are operating
within acceptable parameters.
• Maintaining and monitoring of class 100,000 aseptic manufacturing suites through scheduled sanitizations
and performing viable / non-viable environmental monitoring of air and surfaces within the clean rooms.
• Performed training of newly assigned operators to ensure compliance with applicable procedures in a cGMP
regulated environment.
• Performed evaluations and feedback of operators for annual performance evaluations for Department
Supervision.
• Assisted with developing and implementing a standardized testing procedure for newly assigned operators
known as skilled blocks that aided training and qualification process.
Blow-Fill-Seal Technician 1993-1997
• Perform and assist with lot change activities on BFS machines for commercial manufacturing.
In-Process inspections.
United States Air force 1983-1992
• Wideband communications specialist maintaining multiplexing and de-multiplexing telephone/teletype
transmission/receiving equipment.
• Sensor Maintenance Technician responsible for Weapons Storage Area perimeter surveillance/intrusion
detection equipment for the safeguarding of high end explosives and nuclear weapons.
Skills / Qualifications
• Clean in Place / Sterilize in Place
• Microbiological environmental monitoring
• In Process quality inspections
• Standard Operating Procedures
• Troubleshooting complex equipment
• cGMP
• Gowning qualified
• Basic computer knowledge

2. • FFS machine operation