Sterilization Program Manager

For Sterilization services in the Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Biomedical Engineering, Chemical Engineering, Microbiology, or related field and three (3) years of exposure with EO sterilization validation and/or operations Program Management within the pharmaceutical or medical devices industry.
• Type: Remote
• Bilingual: Spanish and English
• Soft Skills: Excellent teamwork skills
• Experience in:
  • 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).
  • PMP or equivalent certification.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

AS A PIECE OF FITS, YOU WILL:(The day-to-day on the job)

• 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 Provide Technical Oversite: 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 Sterilization & Service Suppliers: Coordinate with interal cross-functional partners to support relationships with contract sterilizers and laboratory service providers.
• Coordinate project scheduling with service suppliers based on prioritization Stakeholder & Change Management: 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

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are you the Next Piece?

Originally posted on Himalayas