Filter Validation Execution Lead

Sanofi•Swiftwater, PA

1d•Onsite

About The Position

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. 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.

Requirements

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.
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.
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.
Knowledge of regulatory expectations around filter design, qualification, and testing (e.g., FDA, EMA, PDA Technical Reports).
2+ years of hands-on experience for qualification and testing of filters used in vaccine manufacturing.
Strong communication skills with the ability to discuss technical topics effectively through both oral and written communication.
Bachelor’s degree in basic sciences, mathematics, engineering, or pharmacy with 2+ years’ work experience in Filter Validation field.
Candidates should possess educational and professional experience, commensurate with the position.
The hired candidate will execute role as an individual contributor.

Nice To Haves

Experience in cleaning, shipping, and Extractables and Leachable (E&L) validation is a plus.

Responsibilities

Designing and executing development and validation studies for sterilizing-grade filters, virus filtration filters, bioburden reduction filters, and vent filters.
Managing the execution of studies aligned with the project schedule and communicating with stakeholders (external labs, the project team, and MSAT Management).
Partnering with MSAT product experts to assess new filtration needs, and support screening studies to define and optimize filter selection.
Drafting, reviewing, and approving documents such as filter validation protocols, reports, Validation Project Plans (VPP), technical assessments, and deviations.
Driving Corrective and Preventive Actions (CAPAs) and Change Controls related to filter development and validation.
Coaching and mentoring junior personnel and contractors on technical knowledge regarding filter validation principles and practices.
Supporting 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.
Supporting all internal and external audits and regulatory inspections related to filter validation.
Participating in the filtration validation expertise network within Sanofi and externally.
Leading and/or participating in any filter validation investigations and troubleshooting activities.
Building and maintaining strong relationships with partners, cross-functional experts, and customers to achieve technical objectives.