Stephen Puryear
cell (510) 774-7302 home (510) 741-0718
stephen_puryear@comcast.net
Summary
An Operations Professional experienced at applying technical, engineering and Quality Process Improvement
principles within State and federally regulated (cGMP) environments. Proven abilities in root cause and risk
assessment, analysis, and management. Strong technical background in measurement and statistical analysis and
its application to both regulatory and business risk. Areas of expertise include:
-- Supply chain vendor analysis -- Risk assessment/failure analysis
-- Process analysis and improvement -- Project Management
-- Advanced statistical analysis -- Internal audits, reports, and trending
Work Experience
Cetus/Chiron /Novartis AG, Emeryville, CA 1989-1991, 1996-2009
Quality Engineer (2005-2009)
Reporting to the Director of Facilities Operations, responsible for resolving Discrepancy Reports (DRs) and
Corrective and Preventive Actions (CAPAs) for group of up to 100 department personnel. Employ audits and
tracking to oversee and maintain the compliance of the department vendor files. Write and submit for QA approval
all new and renewing department vendor descriptions. Tracked, trended, managed and delivered department Key
Performance Indicators (KPIs). Act as engineering resource during the deployment and integration of computer
applications to improve department performance and asset management.
- Transferred 30,000 lines of equipment specifications into a CMMS database without a single error.
- Closed 700 Discrepancy Events with written FDA- auditable reports with a 30 day delivery window.
- Took over vendor file system and increased compliance rating from 19% to 65% in less than a year.
- Published articles on reliability analysis in two professional publications.
- Conducted Monte Carlo analysis to validate current Facilities Operations calibrations practices.
- Presented paper to the 2008 annual Institute of Industrial Engineering Convention (Vancouver, B.C.)
Engineering Specialist (1998-2005)
Lead projects to improve efficiency of department calibration and maintenance functions. Responsible for
supporting calibration technicians. Supported Facilities Operations Department by optimizing calibration resources.
Improved hardware and process infrastructure to allow more timely control and data management. Track, trend
and, wherever possible, reduce calibration OOTs(Out Of Tolerance).
- Managed a $1 M project to purchase install and validate three additional 256-point nodes on a
campus building and process monitoring system. Each addition came on line on schedule and is still
working perfectly.
- Project managed the specification, purchase, validation and training of personnel on a
new “paperless” calibration management system.
- Helped Manufacturing reduce wasteful and expensive OOT's on their scales by 94%.
Senior Instrumentation Technician (1989-1991, 1996-1998)
Installed, validated, calibrated and maintained a wide variety of laboratory, manufacturing and utility equipment and
systems using written SOPs and subject to FDA audits and cGMP statutory guidelines. Where necessary wrote new
procedures. Coordinated activities with equipment users and process owners to optimize maintenance support
within an R&D or Manufacturing environment.
City of Mill Valley Wastewater Treatment Plant, Mill Valley, CA 1991-1996
Master Mechanic
Installed, repaired, calibrated and maintained a wide variety of sensors, controls, and laboratory equipment for a
small (3MGD, summer) waste water facility. Responsible for calibration, maintenance and repair of hazardous gas
sensors that enabled a safe confined space entry program for all plant personnel. Designed and installed controls
and control panel for a successful tertiary treatment pilot plant.
Education
University of Phoenix, Walnut Creek, CA – Masters Degree, Business Administration
Heald College, San Francisco, CA – Associate in Electrical Engineering Technology
College of William and Mary, Williamsburg, VA - Bachelor of Arts, History
Technical
Word, Excel, PowerPoint, Mathematica, Trackwise, Maximo, Mudcats
Relevant Experience
Five year independent study of Refrigerator System Failure Prediction resulting in several papers and presentations
as well as two Novartis Energy Award proposals.
Affiliations
American Society of Quality (ASQ), Society of Maintenance and Reliability Professionals (SMRP), Institute of
Industrial Engineers (IIE), International Society of Automation (ISA), Centre for TPM (Australasia)
Certifications &Licenses
ASQ Certified Quality Manager (Certificate # 05553), ASQ Certified Quality Engineer (Certificate # 39527), State of
California Engineer-in-Training (License #XE188969), EPA Universal Refrigerant Certification (Certificate #
0420387122400).