Job Title: Filter Validation Execution Lead
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 QualificationsExperience: - 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 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.
Educations: - 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.
Terms of employment: - The hired candidate will execute role as an individual contributor.
- The hired candidate will work during normal business hours (8am - 5pm Monday - Friday), but flexibility for occasional work outside of these hours is necessary.
- Preferred Start Date: September 2026
Why choose us? - Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
- Power industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
The salary range for this position is:
$85,500.00 - $123,500.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
