Jeff Felgar
North Manchester
Summary
Accomplished Staff Scientist with extensive experience at DePuy Synthes and Zimmer Biomet, specializing in sterilization, environmental monitoring and cleaning validation. Proven track record in process optimization and risk assessment, leading innovative projects that enhanced compliance and operational efficiency. Adept at microbial testing, laboratory operations, and fostering collaboration across teams to drive successful product development initiatives.
Overview
30
30
years of professional experience
Work History
Staff Scientist, Microbiological Quality & Sterility Assurance
DePuy Synthes
10.2017 - Current
- Enhanced sterility assurance engagement in product development by communicating contamination control policy requirements.
- Supported multiple NPD projects for implants and reusable devices at various completion stages.
- Led validation efforts for irradiation and EO sterilization modalities to ensure compliance.
- Identified master challenge devices/features from retrospective review of approximately 30,000 reusable devices.
- Conducted over 70 cleaning validation tests to support design criteria development across J&J franchise sites.
- Directed innovation team to create, market, and implement digital tools for device cleaning assessments.
- Served as Reprocessing Council Innovation Workstream Lead, developing position papers and research projects.
- Authored position paper rationalizing device features for reprocessing validation and supported MDR initiatives.
Associate Director, Sterilization Technology
Zimmer Biomet
09.2012 - 09.2017
- Managed $4.0 million departmental budget and supervised 20 direct and indirect reports.
- Oversaw sterile product and reusable device review, adoption, and release.
- Conducted equipment and process validation for operational efficiency.
- Implemented quarterly dose audit program across over 30 product families.
- Executed bioburden, sterility, endotoxin, and microbial water testing protocols.
- Administered microbial identification and media preparation processes.
- Validated reusable device processing to ensure compliance with standards.
- Monitored viable/nonviable particulate and compressed air in over 50 controlled rooms.
Principal Microbiologist, Sterilization Technology
Zimmer Biomet
Warsaw
02.2011 - 09.2012
- Acted as global subject matter expert for reusable devices since 2001.
- Developed and executed retrospective cleaning validation strategy for approximately 13,000 legacy Zimmer devices.
- Established test methodology for in-house cleaning validations utilizing spore log reduction, protein, and TOC.
- Created master challenge device families to support steam sterilization product adoption for instrument sets and implants.
- Conducted steam sterilization validations to ensure compliance with industry standards.
- Drafted and implemented global procedure for design and review of reusable devices to enhance reprocessing effectiveness.
- Trained approximately 400 personnel in Sterilization Technology, Quality, Development, and Design across Zimmer globally.
- Performed initial validations and requalifications on all laboratory steam sterilizers and dry heat ovens.
Manager, Environmental Services
Zimmer Biomet
07.2005 - 01.2011
- Oversaw five direct reports across three shifts, ensuring optimal team performance.
- Conducted viable and nonviable particulate monitoring in over 50 controlled environments and 80 laminar flow hoods.
- Administered Laboratory Information Management System (LIMS) to streamline data processes.
- Implemented monthly trend analysis with triggers to enhance Corrective and Preventive Action (CAPA) procedures.
- Developed qualification and requalification programs for environmentally controlled areas.
- Performed risk assessments to determine strategic monitoring locations within facilities.
- Installed and validated continuous monitoring systems for compressed air quality.
Senior Microbiologist, Sterilization Technology
Zimmer Biomet
Warsaw
05.1996 - 07.2005
- Contributed to establishment of new Zimmer manufacturing site in Shannon, Ireland.
- Conducted assessments on reusable devices to verify cleaning and sterilization efficacy.
- Executed audits of sterilization and contract lab suppliers for compliance.
- Administered Laboratory Information Management System (LIMS) to enhance data management.
- Validated steam sterilization, depyrogenation, and lab equipment processes.
- Performed sterility, bioburden, and water testing for microbial and endotoxin contamination.
Education
Master of Science Degree - Biology
Indiana University Purdue University Indianapolis
Indianapolis, IN05-1996
Bachelor of Science Degree - Biology
Ball State University
Muncie, IN05-1993
Skills
- Sterilization and cleaning validation
- Risk assessment
- Microbial testing and laboratory operation
- Compliance documentation
- Process optimization
- Environmental monitoring
Additional Training Certification
- AAMI Process Validation
- Successful Sourcing Interviewing and Selecting
- FISH, A Remarkable Way to Boost Morale and Improve Results
- Successful Solutions for Unacceptable Employee Behavior
- Facilities Net, PMS
- Root Cause Analysis
- Product Experience Reporting
- Lead Auditor Training for ISO 13485, SAM
- StarLIMS Administrator Training
- Cleaning Validation and Critical Cleaning Processes, IVT
- Microsoft Project, Zimmer
- Project Management, IIL
- Industrial Sterilization for Medical Devices, AAMI, Washington DC
Key Work Experience
- Gamma Sterilization
- Contamination Control
- Reusable Device Cleaning/Sterilization
- CAPA
- Environmental Monitoring
- Aseptic Fill
- LIMS
- Purified Water Systems
- Laboratory Management
- Cleanroom Design and Validation
Timeline
Staff Scientist, Microbiological Quality & Sterility Assurance
DePuy Synthes
10.2017 - Current
Associate Director, Sterilization Technology
Zimmer Biomet
09.2012 - 09.2017
Principal Microbiologist, Sterilization Technology
Zimmer Biomet
02.2011 - 09.2012
Manager, Environmental Services
Zimmer Biomet
07.2005 - 01.2011
Senior Microbiologist, Sterilization Technology
Zimmer Biomet
05.1996 - 07.2005
Master of Science Degree - Biology
Indiana University Purdue University Indianapolis
Bachelor of Science Degree - Biology
Ball State University