Sterilization Program Manager

The Sterilization Program Manager is responsible for leading and managing the sterilization project portfolio, including new product launches, validation and revalidation activities, process improvements, and operational support. This role provides technical oversight for Ethylene Oxide (EO) sterilization processes, drives cross-functional collaboration, manages supplier relationships, and ensures compliance with global sterilization regulations and standards.

Key Responsibilities

Program & Portfolio Management

• Lead and manage the full sterilization project portfolio, including:
  • New product launches
    
  • Sterilization validations and revalidations
    
  • Process improvement initiatives
    
• Develop and maintain integrated project plans, timelines, resource allocation plans, and risk registers.
  
• Drive alignment across cross-functional teams including R&D, Quality, Regulatory Affairs, Operations, and Supply Chain.
  
• Facilitate portfolio prioritization and support trade-off decisions with senior leadership.
  
• Establish, monitor, and report key performance indicators (KPIs), project milestones, and program health metrics.
  

Technical Oversight

• Serve as Subject Matter Expert (SME) for EO sterilization processes.
  
• Provide technical guidance related to microbiological and chemical sterilization methods.
  
• Ensure compliance with applicable international regulations, standards, and industry requirements.
  
• Support technical problem-solving and troubleshooting efforts across sterilization-related activities.
  
• Collaborate with internal SMEs to resolve complex sterilization challenges.
  

Sterilization & Service Supplier Management

• Coordinate with internal stakeholders to manage relationships with contract sterilization providers and laboratory service vendors.
  
• Support project scheduling and resource planning with external service suppliers.
  
• Ensure supplier activities align with project priorities, timelines, and business objectives.
  

Stakeholder & Change Management

• Communicate project status, risks, mitigation plans, and key decisions to executive leadership and cross-functional teams.
  
• Lead change control activities associated with sterilization process modifications.
  
• Promote continuous improvement initiatives and process optimization opportunities.
  
• Drive effective stakeholder engagement throughout the project lifecycle.
  

Requirements

• Bachelor’s Degree in:
  • Biomedical Engineering
    
  • Chemical Engineering
    
  • Microbiology
    
  • Or related scientific/engineering discipline
    
• Minimum 3 years of experience in EO sterilization validation and/or sterilization operations.
  
• Strong knowledge of sterilization validation lifecycle activities.
  
• Experience supporting validation, compliance, and process improvement projects.
  

Preferred Qualifications

• PMP Certification or equivalent project management certification.
  
• Experience in medical device, pharmaceutical, or regulated manufacturing environments.
  
• Knowledge of international sterilization standards and regulatory requirements.
  

Required Skills

Sterilization & Validation

• EO Sterilization Processes
  
• Sterilization Validation Lifecycle
  
• Revalidation Activities
  
• Microbiological Methods
  
• Chemical Sterilization Methods
  
• Regulatory Compliance
  

Program Management

• Portfolio Management
  
• Resource Planning
  
• Project Scheduling
  
• Risk Management
  
• FMEA
  
• Risk Registers
  
• KPI Development & Reporting
  
• Cross-Functional Leadership
  

Software & Tools

• Microsoft Office Suite
  
• Microsoft Project
  
• Smartsheet
  
• Agile Methodologies
  

Soft Skills

• Leadership
  
• Strategic Planning
  
• Stakeholder Management
  
• Communication & Presentation Skills
  
• Problem Solving
  
• Continuous Improvement Mindset
  
• Change Management