Sanofi Group Validation Engineer III - 2GCz in Framingham, Massachusetts

Department Description:

The Second Generation Cerezyne program (2GCz) is an initiative to introduce an newly improved Cerezyme process into a newly built manufacturing facility. As part of this, a dedicated team has been formed to drive this project from design to GMO operations. This position will be responsible for the C&Q effort and will be responsible for delivering the facility to “PV Ready” status, in collaboration with Engineering, Operations and Quality. This is a “project based” role which is expected to have an approximate 2 year lifetime.

Position Overview and Key Responsibilities:

  • Leads the C&Q project team from the design and build of the facility and the processing equipment to the completion of validation activities, resulting in the plant being in a “PV ready” state.

  • Directs activities associated with process equipment and GMP utility commissioning, qualification and validation

  • Develops C&Q Plan(s) in conjunction with Engineering, Manufacturing, Automation and where required Quality.

  • Drives the preparation of Project Life Cycle documents to support the project implementation

  • Technical lead for project protocols, execution and reports to ensure the appropriate level of detail and compliance is maintained throughout the C&Q lifecycle.

  • Manage contract resources and contracts under the responsibility of C&Q.

  • Work with Project Controls to generate and issue at minimum monthly progress and cost reports.

  • Communicate metrics for leading and lagging project indicators to communicate C&Q progress on a routine basis.

  • The C&Q Project Lead needs to establish project execution teams at the appropriate time in order to support the implementation of the above key responsibilities.

Leadership Qualifications:

  • Experience leading a team of internal and external resources in the startup, commissioning and qualification of a biopharma manufacturing capex investment project

  • As the C&Q lead, this role must have the ability to interface and influence personnel at all levels across job functions to ensure the best path forward for a given project is identified and implemented

  • Project management experience with focus on commissioning and qualification (both equipment and automation) for large scale projects

Basic Qualifications:

  • Bachelors Degree in an Engineering or Life Sciences discipline

  • Minimum of 10 years experience in either of 1) engineering 2) validation or 3) automation in a life sciences environment

  • Knowledge of regulatory requirements as it relates to C&Q for a pharma facility

  • Experience working with U.S. and European GMP requirements

Preferred Qualifications:

  • Experience working in a time driven capital project environment

  • Experience with creation of life cycle documents, equipment design and procurement, FAT and startup

  • Experience with GMP operations in bulk biologics

Special Working Conditions:

  • Ability to travel up to 30% over a limited time duration (6 months)

  • Willingness to work in an active construction site

  • Ability to work in a clean room environment

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life