Experience

Quality Compliance Partners, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Manager of Automation Validation

  • Oct 2010 - Present

  - PLC / HMI Database and Serialization Validation Life Cycle - Quality Systems, change control and protocol review - Process, Equipment and Utility Validation - CAPA / Nonconformance metrics software – Excel pivot tables, SPC graphics - CAPA investigation formatting and review - PLC / HMI Database and Serialization Validation Life Cycle - Quality Systems, change control and protocol review - Process, Equipment and Utility Validation - CAPA / Nonconformance metrics software – Excel pivot tables, SPC graphics - CAPA investigation formatting and review



ProTracx Inc

• President

  • Jan 2005 - Present

  Regulated Enterprise Management Software: CAPA, specification - validation, project management, risk analysis, training, document control, task / inventory / order management, maintenance, and calibration Regulated Enterprise Management Software: CAPA, specification - validation, project management, risk analysis, training, document control, task / inventory / order management, maintenance, and calibration



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Software Validation Engineer - Consultant

  • Jun 2006 - Jan 2010

  - Software life cycle Cardiac Ablation Controller (RF generation console)- Software life cycle validation of C based original OEM production equipment- E&AS validation of Visual Basic Electrical Discharge Machining (EDM) equipment- Nikon vision inspection / Wire EDM validation

• Quality Engineer

  • Jun 2006 - Dec 2009

  - Managed quality systems: CAPA, nonconformance, vendor management, audits, inter company complaints, and regulatory compliance- Validated equipment, clean utilities, and assembly processes- Software validation: Software Development Life Cycle- Performed ISO / IEC 17025 Laboratory Accreditation metrology audits



B. Braun Medical Inc. (US)

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Consultant

  • Dec 2008 - Mar 2009

  - Firmware / software life cycle validation review of an IV pump software - Analysis of production, quality, and vendor management issue metrics - Firmware / software life cycle validation review of an IV pump software - Analysis of production, quality, and vendor management issue metrics



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Engineer

  • Jul 2005 - Mar 2006

  - Validated SIP/CIP for biological formulation processes - Temperature mapping validation of cool rooms, autoclaves, and depyrogenation ovens using Kaye Validators and Digi’s - Validated SIP/CIP for biological formulation processes - Temperature mapping validation of cool rooms, autoclaves, and depyrogenation ovens using Kaye Validators and Digi’s



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Contractor

  • Mar 2003 - Jul 2005

  - Validation of sterile equipment, formulation, and filling lines - Functional Requirement Specification, Critical Component and Periodic Quality Evaluation of equipment and clean / supporting utilities - Control System engineering, measurement uncertainty, instrumentation, and calibration - Validation of sterile equipment, formulation, and filling lines - Functional Requirement Specification, Critical Component and Periodic Quality Evaluation of equipment and clean / supporting utilities - Control System engineering, measurement uncertainty, instrumentation, and calibration



Genesis Machinery Products

• Pharmaceutical Manufacturing

• Sr. Project Engineer

  • Jun 1999 - Sep 2002

  - Project management, fabrication, machine design, programming, installation, and engineering of sterile vial washers and depyrogenation tunnels for sterile vial filling lines - Skid mounted WFI systems, instrumentation, metrology, HEPA distribution / balancing, fan design, and machine design - Allen Bradley PLC, PanelView HMI programming, validation, FMEA/GAP risk analysis, GAMP, and Life Cycle Development - Specification and integration of vision inspection equipment - Equipment validation: I/O/PQ preparation and execution (fabrication and installation) Show less



Reheis Inc

• Validation Manager

  • Jun 1996 - Jun 1999

  - Validation documentation (drug master files, validation I/O/PQ, SDLC, master plans, SOP's) supporting liquid and tablet formulation, laboratory, and packaging operations - MS .SQL and Access database, Visibar, and RF barcode programming - MRP / ERP (Fourth Shift) database system administration and validation - Engineering and automation of bulk liquid formulation processes - Allen Bradley PLC, PanelView HMI programming - Validation documentation (drug master files, validation I/O/PQ, SDLC, master plans, SOP's) supporting liquid and tablet formulation, laboratory, and packaging operations - MS .SQL and Access database, Visibar, and RF barcode programming - MRP / ERP (Fourth Shift) database system administration and validation - Engineering and automation of bulk liquid formulation processes - Allen Bradley PLC, PanelView HMI programming