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
Company Overview
We 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.