For Process Development services in the Process Engineering area. WHAT MAKES YOU A FIT: The Technical Part: • Bachelor Degree in Engineering and at least five (5) years of experience within the medical devices or pharmaceutical industry. • Bilingual: English and Spanish • Soft Skills: Great attitude and strong desire to learn new skills. • Shift: Administrative, and according to business needs. • Experience in: • Equipment validation and qualification activities, including Installation Qualification (IQ) and Tool Qualification (TQF) • Development and review of validation protocols and reports. • Statistical sampling plans, experimental design, and data analysis. • Design of Experiments (DOE) and execution of experimental protocols. • Technical reports, manufacturing instructions, and experimental documentation. AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) • Support equipment validation (IQ) and tool qualification (TQF) activities. • Develop and review equipment validation protocols and reports, while supporting other functional areas throughout validation activities. • Design, update, and review tools and fixtures using SolidWorks to meet product and test method requirements. • Collaborate with Process Development to qualify new processes, including support for statistical sampling plans and development activities. • Design and develop in-process and receiving quality systems for new processes and components. • Generate equipment documentation, including equipment entries, evaluations, PM, and calibration procedures. • Define the gages, tools, and equipment required for newly developed test methods and generate associated manufacturing instructions. • Design, document, and execute experimental protocols, including DOE, and perform data analysis to identify issues and recommend solutions. • Summarize experimental results and generate technical reports and supporting documentation. • Work cross-functionally with Process Development, R&D, and other departments to accomplish project objectives and support the evaluation of new technologies. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves in 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?