Seth Whitworth Email & Phone Number

Apex, NC, US

Raleigh, North Carolina, United States

Raleigh-Durham, North Carolina Area

Raleigh, North Carolina

West Lebanon NH

• Integral part of a small validation team responsible for company-wide validation activities. This has allowed exposure to a broad spectrum of validation activities.
• As a team member, maintained and executed a yearly revalidation schedule validating autoclaves, depyrogenation ovens, bioreactors, walk in cold rooms, warehouses, stopper washers, Lyophilizer SIP, and vapor hydrogen.
• Developed a global standard document outlining the requirements for the validation of temperature controlled units, reducing protocol development time. Additionally, created pre-approved form-based protocol templates.
• Authored a 21 CFR Part 11 technical report analyzing and documenting the current compliance gaps company-wide for electronic systems, resulting in prescriptive corrective measures for all departments.
• Received recognition as being a key contributor in the commissioning and qualification of a Barrier Isolator used for aseptic fill processes, including the qualification of a vapor hydrogen peroxide generator.

West Lebanon, NH

• Oversaw and coordinated manufacturing activities for Purification and Cell Culture areas, meeting manufacturing schedule needs.
• Received company “High Impact Award” for cleaning validation support for reactor and buffer vessels.
• Managed a team of 4 direct reports, recognized by management for significantly increasing employee engagement.
• Led 5-WHY's problem solving activities for CAPA’s, and performed investigational write-ups for deviations.
• Executed validation activities for a 2500L bioreactor capital expansion project, including 2500L process validation, and operational qualification of Lab systems including Vi-Cell cell viability analyzers, and NOVA.

West Lebanon, NH

• Supported the cell culture manufacturing area from 250mL spinner culture to 1250L bioreactors. Played an integral role during a 2500L bioreactor capital expansion project with a reactor train from 35L to 3300L.
• Background includes validation activities for a Bioreactor Capital Expansion project including SAT, SFAT, FAT, Commissioning, CSOQ and OQ of bioreactors, media filtration skid, and solutions prep tanks. Received the.
• Performed cleaning validation activities for 17 tanks/systems including dirty hold-time and clean hold-time validations.
• Experience in commissioning and validation of bioreactor DCU automation upgrades.