Duane Saltsgaver

Curriculum Vitae

Patents

  • Automatic Fill System, glass coatings
  • Glass Coating Measurement Device
  • Rotation Sensor

Affiliations

  • Member ISPE (International Society for Pharmaceutical Engineers)

Awards

  • Ball Corporation’s President’s Award for outstanding Management contribution
  • U.S. Can’s Endurance Award, 5 years, perfect attendance

Wyeth Biotech, Sanford, North Carolina

  • Project Engineer IV – Engineering Services Group
    • Represented Site Engineering on the construction of a new $58 million Quality Control Laboratory. Liaison between the Site staff and Corporate Engineering staff to insure site standards, regulatory compliance, schedule, operational and technical requirements were met.
    • Managed the procurement, commissioning and transition of 600 items to be moved from existing laboratories into a new QC Laboratory. This involves authoring and executing Risk and Impact Assessments, Commissioning Plans, Protocols and Test Procedures as well managing the logistics for the relocation.
    • Directed the design and installation of two new 750HP Boilers resulting in a 20% increase in steam generation capacity in our Central Utilities Building. This included Design and P&ID Review/Approvals, Installation, Commissioning, Permitting, Controls and Tie-ins to existing utilities.
    • Managed Capital Project involving the design, procurement and Factory Acceptance Testing of a new 100cm Chromatography Column for use within our Phase I/II Purification department allowing improved efficiency for changing from Mono CRM (proteins) to Plasmid CRM (proteins).
    • Core team member of Wyeth Optimization Team focusing on Coordination, Collaboration and Standardization of Departmental Documents and Procedures. Co-authored team charter identifying owners, customers, mission, goals, project management and execution plans for the Engineering and Technical Services departments.
    • Represented Site Engineering on Sustainable Compliance Initiative (SCI) team chartered with establishing and implementing sustainable quality system to establish design and control requirements for GMP facilities.

BioMerieux, Inc. - Durham, North Carolina

  • Senior Process Engineer – Automation Technology Group
    • Managed automation, manufacturing, packaging, design, and facility projects within a regulated and ISO certified facility. Directed and executed equipment, process and facility validations. Provided daily production support, set up and troubleshooting of Aseptic filling and packaging equipment, including liquid fillers, stoppering devices, cappers, labelers, tray loaders, pouching machines, cartoners and vision systems. Execute process improvement efforts and time studies. Author SOP’s (Standard Operating Procedures), DP’s (Departmental Procedures), FICA’s (Failure Investigation/Corrective Action) and ECO’s (Engineering Change Orders).
    • Managed and executed installation, validation and transfer of proprietary automated tray loading machine resulting in 25% increase in final packaging process times and decreasing manual inspection times. This included authoring Master Validation Plan, Validation Protocol, IQ’s (Installation Qualification), OQ’s (Operational Qualification) and formal training of production personnel on equipment start up, operation and maintenance.
    • Directed design, installation and validation of automated labeling machine resulting in 30% increase in process time and 25% decrease in inspection time.
    • Directed transfer of plate coating and pouching production line into new manufacturing area including preparation of bid specifications for facilities modification and process validation to ensure environmental consistency.
    • Maintain equipment trials, capacity, utilization and performance documents and activities.
    • Collaborate with Maintenance Department on new product introduction and preventive maintenance efforts.
    • Author and direct CAPEX (Capital Expenditure) documents and presentations for security, regulatory, capacity, productivity and maintenance activities. This includes project motivation, alternatives, return on investment calculations, resources, business case, summaries, detailed specifications and vendor quotations.
    • Create/update all production routings necessary to track manufacturing standards, labor costs and efficiencies.

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