Lead and manage the full sterilization project portfolio, including new product launches, validations, revalidations, and process improvements
Develop and maintain integrated project plans, timelines, resource maps, and risk registers
Drive cross-functional alignment across R&D, Quality, Regulatory, Operations, and Supply Chain
Facilitate portfolio-level prioritization and trade-off decisions with senior leadership
Establish and report on KPIs, milestones, and program health metrics
Serve as subject matter expert (SME) for EO sterilization processes including supporting microbiological/chemical methods
Ensure compliance with international regulations
Coordinate with internal cross-functional partners to support relationships with contract sterilizers and laboratory service providers

Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Microbiology, or related field
Three (3) years of exposure with EO sterilization validation and/or operations Program Management within the pharmaceutical or medical devices industry
Proficiency in project management tools (MS Project, Smartsheet, or similar)
Strong portfolio management and resource planning capabilities
Experience with risk management frameworks (FMEA, risk registers)
PMP or equivalent certification
Bilingual: Spanish and English

FITS, LLC

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