Career History

Pearl Therapeutics (2016 - present) - Manufacturing Engineer

Bayer Technology Service (2013 - 2016) - Process Analytical Engineer

Certification

Six Sigma Green Belt

Engineer-In-Training

PMI Project Management Training

Allen-Bradley Controls Fundamentals and Troubleshooting


Expertise


  • Experience with the following operations:
    • Fermentation and Cell Culture
    • Purification
    • Homogenization
    • Spray Drying
    • Equipment Washers
    • Clean Utilities
  • Ensure continued operation with minimal downtime at at 24 hour facility.
  • Generation/revision of master batch records and equipment operation, maintenance and calibration procedures.
  • Extensive troubleshooting experience for mechanical and electrical systems.
  • Upkeep of equipment asset data, BOMs, spare parts and master data using SAP and SIMCO CMMS.
  • Deviation Management:
    • Root cause determination using Ishikawa and 5 Why's techniques.
    • Product/Process impact evaluation and recommendation of CAPAs.
  • CAPA Magenament:
    • Implemented solutions to improve process robustness and reduce equipment breakdown.
    • Tracking and evaluation of CAPA effectiveness.
  • Change Control:
    • Performed system and process modifications to increase effiency, eliminate waste, and ensure continuous safe operation.
    • Use of TrackWise, Valgenesis and SAP for change management.
    • Planning and execution of change actions.
  • Validation: authored/reviewed URSs, risk assessments, IOPQ and revalidation documentation, traceability matrices.

  • Initiated, planned, executed and closed CAPEX project up to $1 million.
  • Specification and procurement of equipment.
  • Developed project documentation: charters, scope of work, schedules, procurement plan, KPI report
  • Cost controller for a portfolio of to 30 process improvement projects ranging from $10K to $1 million.
  • Managed vendors and contractors to design and install electrical, mechanical and piping systems
  • Selected projects:
    • Bioreactor Oxygen Control: Tested, implemented and validated new optical dissolved oxygen smart sensors, reducing biofouling signal drift by 50% in perfusion cell culture and maintenance by 75%
    • Washer Cycle Time Reduction: Optimized cycle configurations to wash loads from 8 to 6 and reduced cycle time by 20%
    • Analytical Equipment Lifecycle Management: Upgraded over 80 benchtop conductivity and pH instruments across the plant, harmonizing from four different obsolete models to a single model in all applications. The resulting simplification reduced calibration plan complexity, streamlined operations across different departments, and improved reliability by reducing pH sensor failure rates by 70%.

  • Routine control charting and process capability analysis.
  • Developed statistical process control reports, evaluating batch-to-batch variability of process parameters for early fault detection of purification columns.
  • Created OSI PI and Excel dashboards and macros for route data extraction and monitoring of process data.
  • Automated cost controlling and reporting of a $2.5 million strategic project portfolio using VBA macros.