Filter Validation Execution Lead

Job Title : Filter Validation Execution Lead Location: Swiftwater, PA About the Job Sanofi delivers 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi Global MSAT (Manufacturing Sciences, Analytics, and Technology) acts as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. By driving its own transformation, Global MSAT fulfills an important function by providing day-to-day manufacturing support, focusing on technical and process aspects, effective life cycle management, process robustness enhancement, and yield improvements to optimize performance. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives. Main Responsibilities The Filter Validation Execution Lead is responsible for designing and executing development and validation studies for sterilizing-grade filters, virus filtration filters, bioburden reduction filters, and vent filters. Responsible for managing the execution of studies aligned with the project schedule and communicating with stakeholders (external labs, the project team, and MSAT Management). Partner with MSAT product experts to assess new filtration needs, and support screening studies to define and optimize filter selection. Responsible for drafting, reviewing, and approving documents such as filter validation protocols, reports, Validation Project Plans (VPP), technical assessments, and deviations. Responsible for driving Corrective and Preventive Actions (CAPAs) and Change Controls related to filter development and validation. Responsible for coaching and mentoring junior personnel and contractors on technical knowledge regarding filter validation principles and practices. Support the Subject Matter Expert (SME) to optimize the filter validation program and ensure the program remains compliant with changes to guidelines related to filter validation. Support all internal and external audits and regulatory inspections related to filter validation. Participate in the filtration validation expertise network within Sanofi and externally. Lead and/or participate in any filter validation investigations and troubleshooting activities. Build and maintain strong relationships with partners, cross-functional experts, and customers to achieve technical objectives. About You Basic Qualifications Experience: Demonstrated experience managing execution deliverables to achieve strategic objectives. Preferred: 2+ years of experience in protocol writing, data pack assembly and report writing for filter validation. Contributing to collaboration and harmonization initiatives in support of a vision for future production processes and technologies. Demonstrated ability to work with a high level of autonomy with limited guidance. Experience in cleaning, shipping, and Extractables and Leachable (E&L) validation is a plus. Soft skills: Behaves according to company values and competencies. Encourages and ensures proactive and strong collaboration internally and across functions; forward thinking with an attitude of optimization, efficiency, continuous improvement, and smooth transitions between functions. Use experience and knowledge to propose continuous improvements that deliver efficiency gains. Proactively anticipates and effectively communicates successes, constraints, conflicts, solutions, and actions for resolution. Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate. Technical skills: Knowledge of regulatory expectations around filter design, qualification, and testing (e.g., FDA, EMA, PDA Technical Reports). 2+ years of ha