Sterilization Program Manager

This is a fully remote position, open to applicants in Puerto Rico.

📋 Description

• Oversee and direct the entire sterilization project portfolio, which encompasses new product launches, validations, revalidations, and enhancements to processes.

• Create and uphold comprehensive project plans, timelines, resource allocations, and risk management registers.

• Propel cross-functional collaboration among R&D, Quality, Regulatory, Operations, and Supply Chain teams.

• Facilitate prioritization and trade-off discussions at the portfolio level with senior management.

• Define and report on key performance indicators (KPIs), milestones, and program health metrics.

• Act as the subject matter expert (SME) for EO sterilization processes, including support for microbiological and chemical methods.

• Ensure adherence to international regulatory standards.

• Collaborate with internal cross-functional partners to foster relationships with contract sterilizers and laboratory service providers.

⛳️ Requirements

• Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Microbiology, or a related discipline.

• A minimum of three (3) years of experience with EO sterilization validation and/or operations Program Management in the pharmaceutical or medical device sectors.

• Expertise in project management software (such as MS Project, Smartsheet, or equivalent).

• Strong skills in portfolio management and resource planning.

• Familiarity with risk management methodologies (including FMEA and risk registers).

• PMP certification or an equivalent credential.

• Bilingual proficiency in Spanish and English.

🏝️ Benefits

• A flexible, family-oriented environment that emphasizes the well-being of its resources.