For Process Validation services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Life Science or Engineering and five years of experience in Validation Life Cycle within the Pharmaceutical Industry. Bilingual (English and Spanish) Administrative and according to business needs Experience in: Validation Life Cycle: IQ/OQ/PQ documentation. Process Validation Manufacture regulations. 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) Develop and execute comprehensive process validation plans for new product introductions, process changes, and periodic revalidations. Create and maintain validation documentation including protocols, reports, risk assessments, and (SOPs) in compliance with regulatory standardas. Coordinate and execute validation activities (IQ,OQ,PQ,PPQ) to ensure the reliability and repeatability of manufacturing processes. Collect, analyze, and interpret validation data to identify trends, deviations, and opportunities for process improvement. Utilize statistical tools and methodologies for data analysis and process optimization. Conduct risk assessments and implement risk mitigation strategies throughout the validation lifecycle to ensure product quality and patient safety. Collaborate closely with cross-functional teams including Manufacturing, Quality Assurance, Engineering, and R&D to align validation activities. Stay updated with current regulations, guidelines, and industry best practices related to process validation. Ensure all validation activities are conducted in accordance with regulatory requirements and company policies. Identify opportunities for process optimization, efficiency enhancements, and cost reduction while maintaining compliance and quality standards. Provide training and guidance to manufacturing personnel on validation procedures, protocols, and best practices. 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
