We are looking for a Sr. Scientist for the completion of the cycle development, characterization and qualification activities:
• Lead cycle development for the E-Beam, Isolator, SARA-P, Glove Integrity Tester (GIT) and other equipment.
• Evaluate the cycle development data results.
• Coordinate and support the equipment characterization and qualification activities.
• Create characterization protocols, data spreadsheets, and reports for the Debagger, E-beam, SARA-P, Isolator, Filler Machine, Product Transfer Panel, Paternoster, Tub Identification, Temperature Chamber, and Glove Integrity Tester (GIT).
• Execute and perform the temperature chamber mapping study protocols and report.
• Execute and perform light mapping studies for the product path protocols and report.
• Execute and perform Gage R&R Studies, Method Validation for Syringe Automated Inspection Instrument (DASI); Strategy, protocols and report.
• Support the Single Use qualification activities.
• Create qualification protocols, data spreadsheets, and reports for the Debagger, E-beam, SARA-P, Isolator, Filler Machine, Product Transfer Panel, Paternoster, Tub Identification, Temperature Chamber, and Glove Integrity Tester (GIT).
• Responsible for completing the readiness for execution that includes but are not limited to preparation of materials requisition, execution binders, LIMS labels, Manufacturing and support areas, Training and coordination of execution activities.
• Provide updates on cycle development and qualification, including schedule status, tracking of action items, and assistance with weekly progress meetings, weekly status reporting, and monthly governance meetings.
• Update validation documents.


**Weil Group is proud to be an Equal Employment Opportunity Employer.*