Filter Validation Execution Lead

Location: Swiftwater, PA

About the role

Sanofi delivers 4.3 billion healthcare solutions each year, relying on meticulous planning and detail‑oriented Manufacturing & Supply teams. The Global MSAT (Manufacturing Sciences, Analytics, and Technology) group links R&D and manufacturing, supporting day‑to‑day operations, life‑cycle management, process robustness, and yield improvements. As the Filter Validation Execution Lead you will design and execute development and validation studies for a variety of filters, manage project‑aligned execution, and ensure compliance with evolving regulatory guidelines.

Responsibilities

• Design and execute development and validation studies for sterilizing‑grade, virus filtration, bioburden reduction, and vent filters.
• Manage execution of studies in line with project schedules and communicate with external labs, project teams, and MSAT Management.
• Partner with MSAT product experts to assess new filtration needs and support screening studies to define and optimize filter selection.
• Draft, review, and approve filter validation protocols, reports, Validation Project Plans (VPP), technical assessments, and deviations.
• Drive Corrective and Preventive Actions (CAPAs) and Change Controls related to filter development and validation.
• Coach and mentor junior personnel and contractors on filter validation principles and practices.
• Support the Subject Matter Expert (SME) to optimize the filter validation program and maintain compliance with guideline changes.
• Support 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 filter validation investigations and troubleshooting activities.
• Build and maintain strong relationships with partners, cross‑functional experts, and customers to achieve technical objectives.

Qualifications

• Demonstrated experience managing execution deliverables to achieve strategic objectives.
• 2+ years of experience in protocol writing, data‑pack assembly, and report writing for filter validation (preferred).
• Experience contributing to collaboration and harmonization initiatives for future production processes and technologies.
• Ability to work autonomously with limited guidance.
• Experience in cleaning, shipping, and Extractables & Leachable (E&L) validation is a plus.
• Knowledge of regulatory expectations for filter design, qualification, and testing (e.g., FDA, EMA, PDA Technical Reports).
• 2+ years of hands‑on experience qualifying and testing filters used in vaccine manufacturing.
• Strong oral and written communication skills for technical topics.
• Bachelor’s degree in basic sciences, mathematics, engineering, or pharmacy with 2+ years of relevant work experience.
• Behaves according to company values and competencies; encourages proactive collaboration across functions.
• Proposes continuous improvements that deliver efficiency gains.
• Anticipates and communicates successes, constraints, conflicts, solutions, and actions for resolution.
• Resolves conflicts, removes roadblocks, and escalates when appropriate.

Benefits

• Work alongside a supportive, future‑focused team delivering scientific breakthroughs.
• Endless opportunities to grow talent and advance careers, whether through promotion, lateral moves, or international assignments.
• A thoughtful rewards package that recognizes contributions and amplifies impact.
• Comprehensive health and wellbeing benefits, including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave.
• Opportunity to shape the future of medicine and vaccine delivery with cutting‑edge technology.
• Leverage digital, data, and AI‑driven innovation to power industry‑leading performance.
• Contribute to transforming lives worldwide by delivering life‑changing treatments anytime, anywhere.

Schedule

The role operates during normal business hours (8 am – 5 pm, Monday – Friday) with flexibility for occasional work outside these hours as needed.