Validation Engineer

For Engineering services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s degree in Engineering or related field and at least one (1) yearof experiencewithinthe Pharmaceutical & Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Excellent communication skillsand a positive attitude. Shift: 1st and according to business needs. Experience in: Process validation and equipment qualification (IQ, OQ, PQ) FDA, ISO 13485, GMP, and quality system requirements CAPAs, NCRs, Change Controls, risk assessments, and root cause investigations 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) Develop and execute validation protocols and reports (IQ, OQ, PQ). Support manufacturing by troubleshooting process issues and implementing corrective actions. Lead root cause investigations using tools such as 5 Whys, Fishbone, and FMEA. Manage and support CAPAs, NCRs, Change Controls, and risk assessments. Analyze process data using statistical tools to drive process improvements. Ensure compliance with FDA, ISO 13485, GMP, and internal quality requirements. Collaborate with Manufacturing, Quality, R&D, and Engineering teams on validation and process improvement projects. Support equipment qualifications, process transfers, and new product introductions. Develop and maintain technical documentation, including protocols, reports, and SOPs. WHO WE ARE: We are a Service Provider companydifferent 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 industryclients with top-notch quality talent. We're FITS! Are you the Next Piece? #J-18808-Ljbffr