FITS, LLC
51 - 200 employees
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the IndustryCommitted to SafetyAlways compliant with FDA Regulations & AuditsCost EffectiveProven successful track recordOver ten (10) years of experienceIf you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
Sterilization Program Manager
Job not on LinkedIn
🔥 0 minutes ago
🗣️🇪🇸 Spanish Required
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FITS, LLC
51 - 200 employees
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! Are We The Right Piece For You? We are: Experienced and knowledgeable in the IndustryCommitted to SafetyAlways compliant with FDA Regulations & AuditsCost EffectiveProven successful track recordOver ten (10) years of experienceIf you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
📋 Description
• 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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