Validation Engineer For Vaccines- VIE Contract (W/M)

Sanofi Swiftwater , PA 18370

Posted 3 weeks ago

Responsibilities

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide.

Therefore, only applications that are submitted in English will be considered.

At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our employees, patients and customers.

We are looking for a candidate for a VIE mission of:

Validation Engineer for Vaccines - VIE Contract (W/M)

Responsibilities:

  • Leading the development and validation activities related to implementation of a sterilizing filter at the point of filling for existing Flu products across vial and syringe filling lines

  • Assuring adherence to internal procedures / quality guidelines and external regulatory requirements from development through licensure

  • Driving the technical strategy and project deliverables across the Pharmaceutical Technology (Drug Product) landscape for multiple projects at the Swiftwater site

  • Designing and supporting the execution of implementation of a sterile filter at the point of filling for Flu products across vial and syringe filling lines

  • Authoring/reviewing/approving process development / process validation protocols and reports

  • Authoring/reviewing/approving investigational and/or technical study protocols and reports

  • Leading teams in the design and execution of technical studies and troubleshooting activities and deliver technical solutions

  • Contributing to product submission documentation and defend studies during regulatory inspections

  • Assisting with the design and development of the process for the sterilizing filtration of flu products at point of fill

  • Contributing to the process description for the point of fill filtration within the validation documentation

  • Designing and execute studies to support recirculation at the filter for flu filling to determine adsorption profile during filtration downtimes.

  • Working with Pharmaceutical technology personnel to identify required small scale studies to support large scale development/validation based on expertise in flu formulation and filtration

Requirements:

  • Master Degree in Biologics or Engineering

  • At least 1 year of experience with sterile filtration and filling process development and validation

  • Strong technical writing skills

  • Strong Excel skills

  • Ability to lead and coach teams

  • High Autonomy to work cross-functionally

  • Good communication skills

  • Team spirit

  • Open minded, can do attitude, agility to adapt to the diverse environment

  • Fluent in English

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.


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Validation Engineer For Vaccines- VIE Contract (W/M)

Sanofi