Ultimate Solutions is a trusted provider of packaging industrial automation, serialization, and regulatory compliance for the life science industries. For 20 years, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets.

Description

The successful Sr Validation Scientist will be responsible to Independently provide and/or direct the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the manufacturing. areas.

Responsibilities

• 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.
• Lead cycle development for filling line equipment, like: E-beam, Isolator, SARA-P and Glove Integrity Tester (GIT) ann evaluate the cycle development data results.
• 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.
• 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.
• Support the Single Use qualification activities.
• Create qualification protocols, data spreadsheets and reports for equipments like Debagger, E-beam, Sara-P, Isolator, Filler Machine, Product Transfer Panel, Paternoster, Tub-Identification, Temperature Chamber and Glove Integrity Tester (GIT).
• Update validation documents.

Requirements

• BS in Engineering or Life Sciences 
• 5 years of Scientific experience
• Scientist experience in Product Development, Vial or Syringe Filling  
• Experience with Characterization and Validations
• Service oriented, positive attitude, and self-motivated.
• Strong communication skills; fully bilingual (English/Spanish).
• Allowed to work in the United States without Visa Sponsorship
• Not open for Corp-to-Corp arrangements