Sterilization Program Manager

Flexible & Integrated Technical Services, LLC•,

7d•Remote

About The Position

This role is for a Sterilization Program Manager within the Manufacturing area, focusing on sterilization services. The ideal candidate will manage the full sterilization project portfolio, including new product launches, validations, revalidations, and process improvements. This position requires strong project management skills, technical expertise in EO sterilization, and the ability to drive cross-functional alignment and continuous improvement.

Requirements

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).

Nice To Haves

PMP or equivalent certification.

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.
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.
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.
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.