Sterilization Program Manager

Job Description

Duties and 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.

Required Skills:

• Bachelor’s degree in Biomedical Engineering, Chemical Engineering, Microbiology, or related field Deep knowledge of sterilization validation lifecycle with 3+ years experience with EO sterilization validation and/or operations.

Program Management 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 is a plus.

Technical Skills:

• MS Office, MS Project/Smartsheet, Agile.