Note: The job is a remote job and is open to candidates in USA. FITS, LLC is a service provider company specializing in Engineering, Construction, Maintenance, Utilities, and Specialized Technical services. They are seeking a Sterilization Program Manager to lead and manage the full sterilization project portfolio, ensuring compliance with international regulations and driving continuous improvement in sterilization processes.

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
• Provide Technical Oversite: Serve as subject matter expert (SME) for EO sterilization processes including supporting microbiological/chemical methods
• Ensure compliance with international regulations
• Support other SMEs with technical challenges as required Sterilization & Service Suppliers: Coordinate with internal cross-functional partners to support relationships with contract sterilizers and laboratory service providers
• Coordinate project scheduling with service suppliers based on prioritization Stakeholder & Change Management: Communicate program status, risks, and decisions clearly to executive and cross-functional stakeholders
• Lead change control activities for sterilization process changes
• Drive a culture of continuous improvement and sterilization process optimization

Skills

• 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
• Bilingual: Spanish and English
• Excellent teamwork skills
• 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

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