Division Quality Engineer I

Division Quality Engineer IJoin us at Corning, 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. With our people, we 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.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 livesDamage-resistant cover glass to enhance the devices that keep us connectedOptical fiber, wireless technologies, and connectivity solutions to carry information and ideas at the speed of lightPrecision glass for advanced displays to deliver richer experiencesAuto glass and ceramics to drive cleaner, safer, and smarter transportationSolar polysilicon, wafers, and innovative photovoltaic modules, enabling low-cost solar energy solutionsRole PurposeThis role ensures GxP computerized systems used across Corning Life Sciences remain compliant, validated, and fit for use throughout their lifecycle. It supports system validation, implementation, maintenance, and data integrity through risk-based approaches, while partnering with cross-functional teams to drive standardized, audit-ready validation practices aligned with regulatory and business requirements.Key ResponsibilitiesSupport the standardization of computer systems validation procedures, templates, and documentation practices across division manufacturing and laboratory facilitiesSupport implementation and maintenance of validated computerized systems to ensure compliant, reliable, and available systems that support product quality and business continuityAuthor, 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 expectationsSupport data integrity assessments and compliance activities aligned with applicable requirements for electronic records, electronic signatures, audit trails, system access, backup/recovery, and security administrationPartner 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 requiredParticipate in internal, customer, and third-party audits and inspections, and support audit readiness for computerized systems complianceSupport investigations, root cause analysis, and remediation efforts related to system issues, nonconformances, and validation gapsDrive continuous improvement in CSV processes, validation efficiency, template standardization, and inspection readinessSupport new system implementations and upgrades, including validation impact assessments, test strategy development, and release to operational useLeverage risk-based validation methodologies and applicable lifecycle frameworks to support compliant and efficient validation activitiesProvide technical guidance to cross-functional team members on CSV requirements, system compliance expectations, and validation deliverablesSupport the creation and maintenance of technical documentation that meets business needs and complies with applicable international standards and regulatory requirements (e.g. FDA, EU, ISO, GAMP, ALCOA+)Ensure validation deliverables are inspection-ready, accurate, complete, traceable, and aligned with internal quality system requirementsLead CSV projects of moderate scale and complexityParticipate in and sometimes lead validation activities on larger-scale system implementation or remediation projectsSome travel is required as part of the job responsibilitiesExperiences/Education - RequiredBachelor's degree in a technical or scientific field1–2 years of experience in CSV, quality, IT systems, or regulated environmentsWorking knowledge of GxP and validation lifecycle (IQ/OQ/PQ)Understanding of risk-based validation and data integrity (ALCOA+)Familiarity with change control, deviations, CAPA, and audit readinessExposure to systems such as ERP, LIMS, MES, SCADA, or eQMSStrong attention to detail and technical documentation skillsAnalytical thinker with problem-solving and risk-based decision-making abilityEffective communicator with strong collaboration skillsAble to manage multiple tasks and work independentlyDesired Experience & SkillsLife Science or Pharmaceutical Packaging product application knowledge and experienceInjection Molding manufacturing process knowledge and experienceCertified Quality Engineer recognition by ASQCertified Green or Black Belt recognition by ASQThis 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.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 View email address on click.appcast.io.