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.
