Ben F. Enfinger

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Software Quality Engineer

Ben has more than 30  years experience in design, construction, start-up and validation of laboratory and automated systems.  His expertise includes, project management and hands-on experience for design and validation projects, including computer systems such as LIMS’s, SCADA, DCS (DeltaV, RS/3, etc.), PLC, and laboratory equipment.  Ben has conducted 21 CFR Part 11 assessments, generated gap analysis, remediation plans for both new installs and legacy systems.

 

EXPERIENCE…
  • Group Lead for validation of equipment in a new manufacturing facility.  Responsible for developing, executing and reviewing User Requirements (URS, FRS), engineering specifications and IQ/OQ protocols for custom made equipment as well as custom software.  Performed test method validations and engineering studies to insure the system parameters were achieved using Minitab to ensure the proper cpK is achieved.
  • Responsible for performing test method validations on equipment including UVIR analyzers, pull testers and mass spectrometers.
  • Responsible for development/review of documents including user requirements, design specifications, traceability matrix (RTM) and IQ/OQ, gap analysis , and part 11 assessments for computer related legacy systems.
  • Responsible for the validation of the injection molding machines used to manufacture syringes, from the raw polymer to the finished product.  Project included validating the control system which included Siemens and Allen Bradley PLC’s.
  • Responsible for validation of a vision systems that verifies the packaging line is filling the packages with the proper quantity of product.
  • Responsible for supporting manufacturing process validations, risk analysis, statistical analysis, and gauge R&R.
  • Developed and executed diverse equipment  IQ/OQ/PQs and test method validations.
  • Responsible for the certification of all computer system validation documents including the Delta V  platform and associated PLC’s, Review included URS, Trace Matric, IQ/OQ/PQ and Final Reports.
  • Responsible for performing validation risk assessments for mass spectrometers, autoclaves, particle size analyzers and various other lab equipment witjh embedded software.
  • Group Lead responsible for reviewing, developing and executing user requirements, engineering specifications and IQ/OQ protocols for custom made equipment as well as custom software.
  • Responsible for writing and executing equipment IQ/OQ for a research facility that was being upgraded to a production facility. Duties include research of the existing validation protocols and upgrading them to meet standards.
  • Performed 21 CFR Part 11 assessments, on the automated processes and laboratory equipment.
  • Responsible for computer systems remediation including vendor audits, writing validation plans and user requirements gap analysis, and remediation plans for a DeltaV system, Allen Bradley and Modicon PLC’s in a manufacturing facility.
  • Developed and executed Iq/OQ protocol for a controls system for an HVAC system supporting a packaging area.
  • Assessed the PLC and DCS control systems at various facilities worldwide to identify regulatory conformance to  electronic records and electronic signatures.  Responsible for assessing IT data historians for compliance and validation including ADMIN LIMS, and the AIMS data historians.
  • Responsible for the control systems design including instrument specifications, data base management, and loop checks.  Responsible for the development of loop sheets, and PLC programming.
POSITIONS HELD…
  • Software Quality Engineer – BioTeknica, Inc.
  • Senior Validation Consultant – Atrium Medical Device
  • Validation Consultant – Invacare
  • Quality and Compliance Consultant – Genzyme
  • Project Manager/Validation Consultant – St. Jude Medical
  • Principal Validation Consultant – Teleflex Medical
  • Project Manager/Validation Consultant – Boston Scientific
  • Senior Validation Engineer – Eli Lilly Co.
EDUCATION…
  • B.S., Electrical Engineering – Auburn University
CONTINUING EDUCATION…
  • AutoCad Training
  • Training courses in operation and troubleshooting of Valmet, Provox, Bailey, ABB and Allen Bradley Control Systems, Fisher, and DeltaV.