
51 - 200 employees
🏗️ Construction
🏥 Healthcare
📦 Logistics
Construction • Healthcare • Logistics
FITS, LLC is a service provider company that specializes in integrating engineering, construction, maintenance, utilities, and specialized technical services. With a strong focus on customer care and flexibility, FITS prioritizes the well-being of its resources while delivering high-quality talent to clients in the pharmaceutical, medical device, and manufacturing industries. The company is committed to safety and compliance with FDA regulations, boasting over ten years of successful experience in the industry.
🕒 June 19
🗣️🇪🇸 Spanish Required
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51 - 200 employees
🏗️ Construction
🏥 Healthcare
📦 Logistics
Construction • Healthcare • Logistics
FITS, LLC is a service provider company that specializes in integrating engineering, construction, maintenance, utilities, and specialized technical services. With a strong focus on customer care and flexibility, FITS prioritizes the well-being of its resources while delivering high-quality talent to clients in the pharmaceutical, medical device, and manufacturing industries. The company is committed to safety and compliance with FDA regulations, boasting over ten years of successful experience in the industry.
• 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
• Flexible, family-oriented, and focused on resources' well-being
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