Manager, Biologics Continuous Improvement - Vaccines

SUMMARY OF PURPOSE/JOB RESPONSIBILITIES This position takes a leadership role in identifying and resolving issues related to manufacturing process equipment and/or automated control systems for Continuous Improvement projects for safety, compliance, delivery, and efficiency that impact the supply of bulk Biologic vaccine products. This position drives continuous improvement by leading cross-functional teams to support Biologics Manufacturing to ensure the manufacturing process equipment operates as expected. Develop and execute or assist in the execution of commissioning and qualification documentation. This position requires a high degree of relationship building and communication with operations, engineering, automation, maintenance, quality validation and quality assurance.   KEY ACCOUNTABILITIES Responsibilities include project scope related to manufacturing process equipment, automated control systems, change control development and execution, commissioning and qualification documentation development and execution, test script and protocol completion activities. Collaborate with Automation, Engineering and Maintenance to represent the factory with internal and external suppliers and customers for projects related to automated control systems within Continuous Improvement. Become a Subject Matter Expert (SME) on the state of the industry trends for automated control systems. Through continuing education, remain current with industry knowledge, trends, and best practices. As a SME, provide strategic input required to stay competitive in the bulk vaccine manufacturing market. Attend L1 QDCI board meetings to gather and report out on issues / opportunities existing on the shop floor. Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees. CONTEXT OF THE JOB/MAJOR CHALLENGES The Manager, Continuous Improvement will identify, investigate, troubleshoot, and resolve issues that impact the manufacturing process equipment and/or automated control systems including but not limited to Wonderware and Delta V. The Manager, Continuous Improvement is tasked with leading change. This position is responsible for collaborating with Operations and is expected to work effectively with other supporting functions such as Quality, Engineering, Automation, Maintenance and Manufacturing Technology. The Manager, Continuous Improvement will provide operational and technical input to the Antigen Continuous Improvement Team by direct participation and integration into factory operations. This is accomplished through a high degree of shop floor presence and participation in the focus factory. The Manager, Continuous Improvement will serve as the subject matter expert (SME) within the Antigen Continuous Improvement Team for projects related to manufacturing process equipment, PLC programming, HMI development and technical interface with automated control systems. Along with a portfolio of process improvement initiatives, the Manager, Continuous Improvement may also author and execute commissioning and qualification documentation, lead change controls (CCRs), Corrective and Preventative Actions (CAPAs), provide deviation investigation assistance, trouble-shoot equipment and perform other activities as assigned. REQUIREMENTS EDUCATION/EXPERIENCE BS or MS required in a field related to Engineering, Chemical or Mechanical preferred. The individual should have at least 5 years’ experience in a biotech or pharmaceutical role within the areas of manufacturing, engineering, automation, process development or similar. The individual must have an excellent understanding of cGMP requirements and Continuous Improvement methodologies, along with demonstrated excellence in a technical or scientific position. Must have excellent written and verbal communication skills, as well as the ability to actively and cooperatively lead cross-functional teams. Certifications Wonderware, Delta V, Lean Manufacturing, Six-Sigma, and similar certifications are a plus. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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. #GD-SP #LI-SP PDN 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. 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. Discover more about us visiting www.sanofi.com or via our We Are Sanofi movie As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. Discover what it means to work in Sanofi via this video