**Monday-Friday- 8-4:30pm (flexible)**
This position, Manager Associate Process Engineer, within the Manufacturing Technology (MTech) function of Vaccines Industrial Affairs performs activities supporting the development and validation of industrial downstream processes including Formulation, Filling, Lyophilization and Inspection. The mission of the MTech function is to deliver robust and efficient processes & testing with associated knowledge to transfer to Manufacturing & QC. The Mtech function also provides daily support to manufacturing and QC toward industrial performance excellence. The individual in this position will:
• Plan and execute visual inspection process development and process qualification studies supporting new product introductions and remediation of existing product recipes. Assure adherence to internal procedures / quality guidelines and external regulatory requirements from development through licensure. The individual in this position will contribute to cross-functional teams from various functions in Vaccine Industrial Affairs (VIA) to deliver the following:
• Author process development / process validation protocols and reports
• Author investigational / technical study protocols and reports
• Support project team in the execution of technical studies and development/validation protocols for the automated visual inspection of vials and syringes.
• Create and maintain defect sets for the qualification and optimization of visual inspection processes.
• Support the development of visual inspection processes on Bosch automated inspection machine
• Support Operations by troubleshooting Bosch and Seidenader automated inspection equipment and processes
• Assist in the generation of project schedules with project leader
• Contribute to product submission documentation and defend studies during regulatory inspections
• Support investigations, troubleshooting, CAPA and Change Control activities
THE JOB RESPONSIBILITIES INCLUDE:
• Working with different disciplines (Quality, Operations, Regulatory, and Engineering) in the execution of development and validation studies to industrialize processes for Phase II, III and licensed products to assure commercialization of robust, compliant, and efficient processes for vaccines and biopharmaceuticals.
• Participating in programs that use structured methodologies such as Quality by Design, Design Space and Process Control Strategies in the course of industrial process design, validation and control.
• Supporting project priorities and timelines, and the overall project validation strategy
• Supporting strategic aspects of validation projects with minimal supervision
• Bachelor of Science Degree in an Engineering or Science discipline
• 2-5 years of experience in Visual Inspection Process development / validation
• Experience with Eisai, Seidenader, and/or Bosch automated inspection machines
• Experience with the automated inspection of lyophilized products
• Experience with the qualification of CCIT machines
• Strong technical writing and verbal communication skills
• eDoc, SAP, Phenix proficiency
• Experience in Formulation, Filling, and Lyophilization process development / validation
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.
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.