For Process development and 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: Process Development projects Equipment Validation IQ/OQ/PQ for equipment Manufacturing process ( Heat Bonding, Injection Molding, Vision Systems). Automated equipment (PLC/Servos/Pneumatics/ Sensors), 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) Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification and develop MVP for new processes or products. Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities. Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures. Design and develop in-process and receiving quality systems for new processes and components. Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required. Define gages, tools and equipment for the test methods developed. Generate manufacturing instructions for new processes being developed. Be able to manage process development projects from conception to implementation, ensuring project deadlines and objectives are met. Familiarity with a variety of technologies and equipment used in the industry. Manufacturing processes (Laser Welding, Stringing, Staking, Heat Bonding, Injection Molding, Vision Systems). Experience with automated equipment (PLC/Servos/Pneumatics/ Sensors), Ability to identify areas of improvement in processes and develop strategies to optimize the efficiency, quality and/or yield of those processes. Understand and evaluate the risks associated with these manufacturing processes and develop ideas/solutions to minimize these risks. 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
