Sterilization Assurance Quality Engineer

Sterilization Assurance Quality Engineer

** Date:
** Jul 2, 2026

*
* Location:

** Durham, NC, US, 27712

Tewksbury, MA, US, 01876

** Company:
** Corning

Requisition Number: 76297

** 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*
* The Sterilization Assurance Quality Engineer is accountable and responsible for ensuring the sterility assurance program across CLS complies with specific policies, regulations and standards as they relate to sterilization or aseptic processing. They are responsible for providing support for all sterility assurance activities within CLS manufacturing facilities. Implements policies and procedures at all of CLS locations relating to Quality consistent with the Sterilization Center of Excellence (SCOE), Divisional, and Corporate Quality/Regulatory programs and policies and ensures compliance with regulatory requirements.

This position reports to the Sterilization Assurance Program Lead.

** Key Responsibilities*
* + Support sterilization and aseptic processing programs for Corning Life Sciences products at the Division and Site level.

+ Help implement changes that improve sterilization compliance, supply flexibility, and process efficiency.

+ Support product transfers to new sterilization methods, sites, or suppliers.

+ Help standardize sterilization requirements such as dose ranges, SAL, and validation methods.

+ Provide technical support for sterility claims for terminally sterilized and aseptically processed products.

+ Escalates any issues or concerns appropriately to ensure actions are taken that are commensurate with the risk.

+ Maintain knowledge of applicable standards and regulations, including ISO 11137, ISO 11135, ISO 11737, ISO 13408, ISO 14937, and ISO 13485.

+ Work with Quality, Regulatory, Manufacturing, R&D, Engineering, Supply Chain, and external partners on sterility assurance activities.

+ Support sterilization and aseptic processing validations, requalification's, and change assessments.

+ Review bioburden, sterility, environmental monitoring, and other microbiological data to support sterility assurance.

+ Support investigations related to sterilization, aseptic processing, contamination control, and sterility issues.

+ Maintain procedures, protocols, reports, and other records related to sterilization and aseptic processing.

+ Support risk assessments, audits, inspections, and training related to sterility assurance.

** Experiences/Education - Required*
* + Bachelor's degree in Life Sciences, Chemistry or Engineering or related field of study.

+ 1-3 years related experience with sterilization, sterilization assurance, aseptic processing in a manufacturing environment.

+ Working knowledge of sterilization and…