Sterilization Program Manager

Mg Staffing Group

13h

About The Position

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.

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.

Nice To Haves

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

Responsibilities

• 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.
• 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.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level