[Remote] Sterilization Program Manager

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.ResponsibilitiesLead and manage the full sterilization project portfolio, including new product launches, validations, revalidations, and process improvementsDevelop and maintain integrated project plans, timelines, resource maps, and risk registersDrive cross-functional alignment across R&D, Quality, Regulatory, Operations, and Supply ChainFacilitate portfolio-level prioritization and trade-off decisions with senior leadershipEstablish and report on KPIs, milestones, and program health metricsProvide Technical Oversite: Serve as subject matter expert (SME) for EO sterilization processes including supporting microbiological/chemical methodsEnsure compliance with international regulationsSupport 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 providersCoordinate project scheduling with service suppliers based on prioritization Stakeholder & Change Management: Communicate program status, risks, and decisions clearly to executive and cross-functional stakeholdersLead change control activities for sterilization process changesDrive a culture of continuous improvement and sterilization process optimizationSkillsBachelor's Degree in Biomedical Engineering, Chemical Engineering, Microbiology, or related fieldThree (3) years of exposure with EO sterilization validation and/or operations Program Management within the pharmaceutical or medical devices industryBilingual: Spanish and EnglishExcellent teamwork skillsProficiency in project management tools (MS Project, Smartsheet, or similar)Strong portfolio management and resource planning capabilitiesExperience with risk management frameworks (FMEA, risk registers)PMP or equivalent certificationCompany OverviewWe are a Service Provider company different from the rest. It was founded in 2008, and is headquartered in Guaynabo, NA - Puerto Rico, PRI, with a workforce of 201-500 employees. Its website is https://www.fitspr.com.