Sterilization Program Manager

Flexible & Integrated Technical Services, LLC (FITS) is hiring a Sterilization Program Manager in Puerto Rico to lead end-to-end sterilization initiatives that keep pharmaceutical and medical device manufacturing safe, compliant, and on schedule. If you live and breathe EO sterilization, program management, and cross-functional leadership, this contract role is your next piece.

About the Role

As Sterilization Program Manager, you will own the sterilization project portfolio within a fast-paced manufacturing environment in Puerto Rico. This is a bilingual (Spanish and English) contract position centered on driving validations, process improvements, and regulatory compliance while serving as the technical anchor for ethylene oxide (EO) sterilization.

Key Responsibilities

• Direct the complete sterilization portfolio, spanning new product launches, validations, revalidations, and continuous process enhancements.
• Build and maintain unified project plans, schedules, resource maps, and risk registers.
• Align efforts across R&D, Quality, Regulatory, Operations, and Supply Chain teams.
• Guide portfolio prioritization and trade-off discussions alongside senior leadership.
• Define, track, and report KPIs, milestones, and overall program health.
• Act as subject matter expert for EO sterilization, including supporting microbiological and chemical methods, and ensure adherence to international regulations.
• Partner with internal teams to manage relationships and scheduling with contract sterilizers and laboratory service providers.
• Communicate status, risks, and decisions to executives, lead change control for sterilization process changes, and champion a culture of continuous improvement.

Qualifications

• Bachelor's degree in Biomedical Engineering, Chemical Engineering, Microbiology, or a related discipline.
• Three years of experience in EO sterilization validation, operations, or program management within the pharmaceutical or medical device industry.
• Fluency in both Spanish and English.
• Hands-on skill with project management platforms such as MS Project or Smartsheet.
• Strong portfolio management and resource planning abilities.
• Familiarity with risk management frameworks like FMEA and risk registers.
• PMP or equivalent certification.
• Outstanding teamwork, a customer-first mindset, and a passion for innovation.

About Flexible & Integrated Technical Services, LLC

FITS is a service provider that does things differently, treating every team member, resource, and client like family. We unite Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across Puerto Rico and the mainland US, delivering high-quality talent to pharmaceutical, medical device, and manufacturing clients while keeping our people's well-being front and center.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.