Sterilization Program Manager
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Job Description
Sterilization Program Manager overseeing sterilization project portfolios in the medical devices sector. Leading validations, process improvements, and cross-functional teamwork within the company.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- Flexible, family-oriented, and focused on resources' well-being
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