A self-motivated individual with extensive experience in regulated healthcare product manufacturing industry. Strong expertise in Quality and Validation Engineering. Proven ability to take on new assignments and follow through to completion. Strong expertise in utilizing quality engineering tools including SPC, DOE, Gauge R&R and tolerancing analysis, control plans, capability analysis, FMEA, etc.
bioMerieux Industry 2002 – March 29, 2018
Senior Validation Engineer
Plan, execute and document all activities related to validation and re-validation of equipment, processes and software used in the manufacture of In-Vitro diagnostic microbiological products to assure compliance with FDA GMP, USP, ISO (9001, 13485, 17025) internal and external requirements and regulations. Examples of validations completed include: bulk steam sterilization systems; autoclaves; incubators; freezers; refrigerators; material storage areas; aseptic and non-aseptic fill processes; water purification systems; packaging and labeling systems; continuous monitoring system software and hardware.
Development and continued support of equipment and processes used for steam sterilization of product and materials used to produce products (bulk sterilization of materials for aseptic filling, terminal sterilization of non-aseptic fills, dry good and raw material component sterilization, etc.). Also developed and supported terminal sterilization processes utilizing gamma, e-beam and ethylene oxide gas sterilization. Specific examples included development of sterilization cycles encompassing 4 autoclaves and 9 bulk sterilizers used for the production of 400+ products.
Lead projects aimed at process improvement, optimization and quality improvement for new and existing processes and equipment. Specific examples included; development and installation of new bottle packaging equipment that resulted in reduction of headcount from 10 to 2 personnel and decreased time to package by over 400%; developed sterilization processes using Fo and steam-air mixture capabilities to reduce risks, simplify processes and increase safety related to sterilization of liquids in bottles.
Manage equipment and instrumentation calibration program for all production process and laboratory / test equipment. Included management of external calibration suppliers as well as execution of calibrations conducted internally. For year 2017 completed 499 calibrations with an on-time metric of 99.6%.
Manage other support activities for scheduled maintenance and certification of equipment and instrumentation (i.e. laminar flow hoods, biological safety cabinets, clean room and fill line HEPAs, lab equipment cleanings, etc.). For year 2017 completed approximately 400 scheduled tasks related to cleanings, cleanroom HEPA filter certifications and HEPA filtered lab laminar flow and biohazard hood certifications.
Manage environmental monitoring system that utilizes RF based sensors to continually monitor temperatures, humidity and pressures for manufacturing process equipment, test equipment and controlled environments throughout facility. For year 2017 this included continual monitoring, alarm response and corrective action responses for 231 sensors located throughout the facility.
Provide daily technical support to manufacturing for equipment and manufacturing process (product compounding, sterilization, aseptic and non-aseptic fill lines, packaging and labeling equipment, QC test instrumentation and equipment, data management systems, etc.).
Provide hardware and software support for product labeling systems including completing verifications of product labels prior to implementation. For year 2017 completed project to implement HIBC compliant labeling using 2D Datamatrix codes for FDA regulated products. Also laid groundwork for applying HIBC compliant labeling to non-FDA regulated products by installing appropriate hardware and working on project to implement new label generation systems globally at all Biomerieux facilities.
Perform investigations and support for NCMR and CAPA activities related to equipment and environmental deviations. For year 2017 closed two CAPA investigations and 52 non-conformance investigations.
Rexam Medical Packaging 1995 – 2002
Senior Process Engineer 2000 - 2002
Full time 6-Sigma blackbelt performing activities and projects relating to process re-engineering aimed at achieving efficiency and quality improvement, cost reductions and general problem solving.
Liaison to upper management and key customers to coordinate activities relating to 6-Sigma program project selection, activities management and training.
Senior Quality Engineer 1995 - 2000
Responsible for all activities relating to quality control and GMP compliance of blown film, printing, laminations and converting operations.
Work with management, customer service, sales and customer representatives on resolving customer complaints.
Perform internal and external audits to assure compliance with regulatory, ISO, internal and external requirements.
Work with other QC, production, engineering and management personnel to employ 6-Sigma and general statistical methodologies aimed at process improvement and problem solving.
Serve as member of internal Corporate Quality Council and external member of organizations such as PDA, ASTM and Flexible Packaging Association to develop and promote industry standards.
Baxter Healthcare Corporation 1976 – 1995
Senior Quality Engineer 1989 - 1995
Apply statistical methodologies such as SPC, Gage R&R, Capability Studies, Design of Experiments to improve and maintain quality of processes and products.
Perform internal and external audits.
Served on core team to develop and maintain ISO 9000 compliant quality system.
Systems Coordinator 1984 - 1989
Management of Information Technology systems including hardware and software on PC network and IBM AS/400 platforms.
Perform custom programming to support management, planning, manufacturing, QC, engineering and warehousing activities.
Various Production Positions 1976 - 1984
Various positions in manufacturing starting as machine operator then graduating levels to include master operator, trainer and shift supervisor.
Education and Professional Certifications:
Attended John A. Logan College and Southern Illinois University (1973 to 1975) for general studies and majoring in fine arts and education. Later completed extended coursework at College of Lake County and Roosevelt University to supplement education in areas of mathematics and engineering statistics as applied to quality engineering and 6-sigma process improvement methodologies.
Through American Society for Quality (ASQ) completed coursework and attained Certified Quality Engineer (CQE). Through Baxter Healthcare Quality Technologies completed coursework and attained various certifications such as Certified 6-Sigma Engineer, Certified Quality Auditor, Certified SPC Trainer. Through Rexam 6-Sigma Blackbelt program attained certification as 6-Sigma Blackbelt.
Computer Software Skills
Various office applications including MS Office Outlook, Word, Excel, Powerpoint, Project. Statistical applications including Minitab, Statgraphics, DBQ (Murphy Software) and Echip DOE. Quality Management System CAPA and NCMR applications documentation support systems using Trackwise software. Environmental monitoring systems using Hanwell (IMC Group) and Labguard (Biomerieux) software/hardware. Validation data logging systems and software included Kaye Validator and Valprobe systems and Mesa Labs data loggers. Bartender labeling software.