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?
Flexible & Integrated Technical Services, LLC (FITS) is a service provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services. The company specializes in providing top-quality technical talent to Pharmaceutical, Medical Device, and Manufacturing industry clients, with a particular focus on sterilization services and validation. FITS operates across the Caribbean region and the United States, emphasizing a family-oriented culture centered on employee well-being. The company distinguishes itself through its commitment to treating employees as the most important part of the organization while delivering specialized technical expertise in areas such as Ethylene Oxide sterilization processes, environmental monitoring, and regulatory compliance.
