About Us Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai. Job Description Catalyx is seeking an OSI PI Engineer who will be responsible for designing and maintaining PI Vision dashboards, managing PI tags, and assisting with change control and validation execution within a regulated GxP environment. Who We Are Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit www.catalyx.ai. The Role Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organizations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations. Join a growing service delivery team providing project implementation, technical support, and customer training for specialized automation and software solutions used in regulated manufacturing environments. You’ll play a key role in ensuring customer success across European sites through hands-on system setup, validation, and troubleshooting. Responsibilities • Design and configure intuitive, user-friendly PI Vision screens to support manufacturing, quality, and engineering teams. • Add and manage PI tags to integrate new equipment and processes into the PI System. • Support change control activities, including system documentation, risk assessments, and impact evaluations in accordance with GMP standards. • Assist in the execution of validation protocols (IQ/OQ/PQ), including testing, deviation documentation, and final report generation. • Troubleshoot PI System issues (data gaps, tag configuration errors, interface problems) and coordinate with automation and IT teams for resolution. • Ensure compliance with FDA regulations, GxP guidelines, and data integrity standards (ALCOA+). • Provide support during audits, inspections, and internal reviews, ensuring PI-related documentation is complete and accurate. Requirements Requirements: • Bachelor’s degree in Engineering, Computer Science, Information Systems, or a related technical field. • 5+ years of experience with the OSIsoft PI System in a pharmaceutical or GMP-regulated environment. • Hands-on experience with PI Vision, PI Data Archive, and PI Interfaces. • Strong understanding of validation practices and change management in regulated industries. • Familiarity with manufacturing automation systems (e.g., DeltaV, Rockwell, SCADA, DCS) and data integration. • Excellent communication, documentation, and teamwork skills. Why Join Catalyx? At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.