Sterilization Assurance Quality Engineer

Corning Incorporated; Durham (NC); On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

Bonuses & incentives

Pension plan

401(k) matching

Health & wellness benefits

Paid time off

Parental leave

Job summary

Corning Incorporated in Durham, NC, is seeking a Sterilization Assurance Quality Engineer to oversee the sterility program across CLS facilities, ensuring compliance with ISO standards and regulatory requirements. You will support sterilization and aseptic processing for Life Sciences products and collaborate with Quality, Regulatory, Manufacturing, R&D, and suppliers.

The ideal candidate has a life sciences or engineering degree, 2+ years in a regulated environment, and strong data analysis and

Qualifications

• Bachelor's degree in Life Sciences, Chemistry or Engineering.
• 1–3 years related experience with sterilization, sterilization assurance, aseptic processing in a manufacturing environment.
• Working knowledge of sterilization and sterility assurance principles for medical device or life sciences products.
• Familiarity with ISO standards such as ISO 11137, ISO 11135, ISO 11737, ISO 13408, ISO 14937, and ISO 13485.
• Experience supporting sterilization validation, dose audits, requalification, or aseptic processing activities.
• Ability to review and interpret microbiological and environmental data, validation reports, and technical documentation.
• Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA.
• Strong written and verbal communication skills.
• Good organizational skills and attention to detail.
• Ability to work with cross-functional teams and external partners.
• Proficiency with standard business software and data analysis tools.
• Track record of delivering results.
• 2+ years’ experience in a regulated manufacturing or life sciences environment.
• Familiarity with statistical methods used in validation, sampling, and trend analysis.
• Experience supporting audits, inspections, and regulatory submissions.

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.

Skills

Sterilization principles

Data analysis

Regulatory compliance

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Life Sciences/ Chemistry/ Engineering

Tools

ASQ Certifications

Job description

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

TheSterilization 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 sterility assurance principles for medical device or life sciences products
• Familiarity with applicable standards such as ISO 11137, ISO 11135, ISO 11737, ISO 13408, ISO 14937, and ISO 13485
• Experience supporting sterilization validation, dose audits, requalification, or aseptic processing activities
• Ability to review and interpret microbiological and environmental data, validation reports, and technical documentation
• Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA
• Strong written and verbal communication skills
• Good organizational skills and attention to detail
• Ability to work effectively with cross-functional teams and external suppliers or laboratories
• Proficiency with standard business software and data analysis tools
• TRAINING ALIGNED WITH MANUFACTURING & ENGINEERING INSTITUTE LEARNING JOURNEY
• Track record of delivering results
• Demonstrated knowledge in a technical field
• Project team membership
• 2+ years’ experience in a regulated manufacturing or life sciences environment
• Familiarity with statistical methods used in validation, sampling, and trend analysis
• Experience supporting audits, inspections, and regulatory submissions
• Ability to assess the impact of product, packaging, or process changes on sterility assurance
• Strong problem-solving and technical investigation skills
• ASQ Certifications (CQA / CQE / CMQOE) preferred.
• Works well with cross-functional teams
• Communicates clearly with technical and non-technical audiences
• Uses good judgment to solve technical and compliance issues
• Manages multiple tasks and deadlines effectively
• Identifies problems and helps drive solutions
• Adapts well to changing business and regulatory needs
• Works independently and as part of a team
• Maintains clear documentation and follows through on actions
• Focuses on customer needs, product quality, and compliance

This position does not support immigration sponsorship.

The range for this position is $67,237.00 - $92,451.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education.

A job that shapes a life.

Corning offers you the total package.

Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one.

• Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win.
• As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit with fixed contributions that grow throughout your career. Combined with matching contributions to your 401(k) savings plan, Corning’s total contributions to your retirement accounts can reach between 7% and 12% of your pay, depending on your age and years of service.
• Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.
• Getting paid for our work is important, but feeling appreciated and recognized for those contributions motivates us much more. That’s why Corning offers a recognition program to celebrate successes and reward colleagues who make exceptional contributions.

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.

Corning is committed to providing equal employment opportunities and considers requests for reasonable accommodations in accordance with applicable laws. Individuals with disabilities or sincerely held religious beliefs may request reasonable accommodations to participate in the application or interview process, perform essential job functions, or access other benefits and privileges of employment. To submit a request for reasonable accommodation related to disability or religion, please contact us at [e-mail].