Seth Whitworth Email & Phone Number

Apex, Nc, Us

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 peroxide decontamination of an aseptic fill isolator. •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 for walk-in cold rooms and freezers.•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 Bioflex analyzers.

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 company “High Impact Award” for contributions made.•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.