For Validation services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering, Computer Science or Information Technology and five years of experience in implementing and supporting Manufacturing Execution System (MES) and Electronic Batch Records Systems (EBR) in a pharmaceutical or biotechnology manufacturing environment. Excellent problem-solving skills and ability to troubleshoot complex technical issues. Strong communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams. Bilingual (English and Spanish) Administrative and according to business needs Experience in: system validation, qualification, and documentation practices in a regulated environment. MES and EBR software platforms such as Werum PAS-X, Rockwell Automation PharmaSuite, Emerson Syncade, or equivalent. Manufacturing processes, Good Manufacturing Practices (GMP), and regulatory requirements, including FDA 21 CFR Part 11. Project management experience preferred, including the ability to manage multiple projects simultaneously and deliver results within established timelines. 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) Lead the implementation and configuration of MES and EBR systems, ensuring alignment with manufacturing processes and compliance standards. Collaborate with cross-functional teams to define system requirements, develop user specifications, and oversee system integration activities. Customize and configure MES and EBR software modules to meet specific manufacturing needs, including batch processing, recipe management, and electronic recordkeeping. Provide technical support and troubleshooting expertise to resolve system issues, optimize performance, and ensure uninterrupted manufacturing operations. Develop and maintain system documentation, standard operating procedures (SOPs), and training materials for end-users. Conduct user training sessions to ensure proper utilization of MES and EBR systems and adherence to established procedures. Collaborate with Quality Assurance (QA) and Regulatory Affairs teams to ensure compliance with relevant regulatory guidelines, such as FDA 21 CFR Part 11. Implement data analytics and reporting capabilities within MES and EBR systems to facilitate real-time monitoring, data analysis, and decision-making. Stay abreast of industry trends, emerging technologies, and best practices related to MES and EBR systems, and recommend continuous improvement initiatives. Participate in cross-functional projects and initiatives aimed at enhancing manufacturing operations efficiency, productivity, and quality. 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
