For Equipment Validation services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering and five years of experience in Validation Life Cycle within the Medical Device Industry. Bilingual (English and Spanish) Administrative and according to business needs Experience in: Troubleshooting of equipment. Validation Life Cycle: IQ/OQ/PQ for equipment Validation of Manufacturing Equipment. 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 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 take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Conduct process equipment installation/operational/performance qualification studies to test their functionality. Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters. Identify and evaluate equipment enhancements to support intended qualified operational ranges. Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications. Support process capability and statistical analysis related to equipment performance. Support the periodic review of equipment/system qualifications studies. Generate & execute protocols; IQ, OQ, PQ Generate and execute equipment/software validation protocols (IQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities. Validation engineering support of process and/or equipment upgrades, replacements, and modifications in manufacturing environment. Develop, organize, analyze and present interpretation of results for operational issues or validation engineering projects of significant scope and complexity. 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? Powered by JazzHR
