EO Sterilization Program Lead

Medial Group; Juncos (PR); On-site; USD 95,000 - 135,000; Full time

Job summary

Medial Group is seeking a Sterilization Program Manager in Juncos, Puerto Rico. The role leads the EO sterilization project portfolio, driving launches, validations, and process improvements, while providing SME guidance on microbiological and chemical sterilization methods.

You will coordinate with R&D, Quality, Regulatory Affairs, Operations, and Supply Chain to ensure regulatory compliance and on-time delivery of sterilization programs across global products.

Qualifications

• Bachelor\'s degree in Biomedical Engineering, Chemical Engineering, Microbiology, or related field.
• Minimum 3 years of EO sterilization validation or sterilization operations experience.
• Strong knowledge of sterilization validation lifecycle activities and regulatory compliance.

Responsibilities

• Lead and manage EO sterilization projects including new product launches and validations.
• Develop integrated project plans with timelines, resource allocation, and risk registers.
• Coordinate cross-functional teams (R&D, Quality, Regulatory Affairs, Operations, and Supply Chain).
• Establish KPIs and monitor project milestones and program health.
• Coordinate with contract sterilization providers and lab service vendors.

Skills

Project management

EO sterilization

Cross-functional collaboration

Regulatory compliance

Problem solving

Education

Biomedical Engineering

Chemical Engineering

Microbiology

Related scientific/engineering discipline

Job description

Medial Group is seeking a Sterilization Program Manager in Juncos, Puerto Rico. The role leads the EO sterilization project portfolio, driving launches, validations, and process improvements, while providing SME guidance on microbiological and chemical sterilization methods.

You will coordinate with R&D, Quality, Regulatory Affairs, Operations, and Supply Chain to ensure regulatory compliance and on-time delivery of sterilization programs across global products.