Division Quality Engineer I
CorningAbout the role
Requisition Number: 75993
The company built on breakthroughs.
Join us.
Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.
How do we do this? With our people. They break through limitations and expectations – not once in a career, but every day. They help move our company, and the world, forward.
At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.
Come break through with us.
Corning’s businesses are ever-evolving to best serve our customers, industries, and consumers. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets. We are changing the world with:
- Trusted products that accelerate drug discovery, development, and delivery to save lives
- Damage-resistant cover glass to enhance the devices that keep us connected
- Optical fiber, wireless technologies, and connectivity solutions to carry information and ideas at the speed of light
- Precision glass for advanced displays to deliver richer experiences
- Auto glass and ceramics to drive cleaner, safer, and smarter transportation
- Solar polysilicon, wafers, and innovative photovoltaic modules, enabling low-cost solar energy solutions
Role Purpose
Key Responsibilities
- Support the standardization of computer systems validation procedures, templates, and documentation practices across division manufacturing and laboratory facilities
- Support implementation and maintenance of validated computerized systems to ensure compliant, reliable, and available systems that support product quality and business continuity
- Author, review, execute, and approve CSV lifecycle documentation, including:
- Ensure computerized systems remain in a validated state through effective management of:
- Participate in system risk assessments and help define validation strategies based on system complexity, intended use, GxP impact, and regulatory expectations
- Support data integrity assessments and compliance activities aligned with applicable requirements for electronic records, electronic signatures, audit trails, system access, backup/recovery, and security administration
- Partner with IT, Automation, Quality, Engineering, and system owners to support implementation, qualification, and lifecycle management of systems such as:
- Support supplier assessment and qualification activities for software vendors, service providers, and third-party system integrators as required
- Participate in internal, customer, and third-party audits and inspections, and support audit readiness for computerized systems compliance
- Support investigations, root cause analysis, and remediation efforts related to system issues, nonconformances, and validation gaps
- Drive continuous improvement in CSV processes, validation efficiency, template standardization, and inspection readiness
- Support new system implementations and upgrades, including validation impact assessments, test strategy development, and release to operational use
- Leverage risk-based validation methodologies and applicable lifecycle frameworks to support compliant and efficient validation activities
- Provide technical guidance to cross-functional team members on CSV requirements, system compliance expectations, and validation deliverables
- Support the creation and maintenance of technical documentation that meet
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