Division Quality Engineer I

Corning Inc.; City of Corning (NY); On-site; USD 67,237 - 92,451; Full time

Benefits offered by this job

Bonuses & incentives

Pension plan

401(k) matching

Healthcare coverage

Parental leave

Family support

Life insurance

Disability coverage

Paid time off

EAP

Job summary

Corning Inc. seeks a CSV Specialist to ensure GxP computerized systems across Life Sciences remain compliant, validated, and fit for use through their lifecycle.

The role partners with IT, Automation, Quality and Engineering to support system validation, risk-based approaches, data integrity and audit readiness, with some travel involved.

Qualifications

• Bachelor3 degree in a technical or scientific field.
• 1201 years of experience in CSV, quality, IT systems, or regulated environments.
• Working 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 readiness.
• Exposure to ERP, LIMS, MES, SCADA or eQMS.
• Strong attention to detail and technical documentation skills.
• Analytical thinker with problem-solving and risk-based decision-making ability.
• Effective communicator with strong collaboration skills.
• Able to manage multiple tasks and work independently.

Responsibilities

• Standardize CSV procedures and documentation across facilities.
• Maintain validated systems to ensure quality and business continuity.
• Author, review, execute, and approve CSV lifecycle documents.
• Ensure systems stay validated; manage validation state and changes.
• Participate in risk assessments and define validation strategies.
• Support data integrity assessments and electronic records compliance.
• Partner with IT, Quality, Engineering on lifecycle management of systems.
• Support supplier assessments and audits; remediation efforts as needed.
• Lead CSV projects of moderate scale and complexity.
• Some travel may be required.

Skills

CSV experience

Quality systems

Regulated environments

Documentation skills

Analytical thinking

Cross-functional collaboration

Education

Bachelor3 degree in a technical or scientific field

Tools

ERP

LIMS

MES

SCADA

eQMS

Job description

Location: Corning, NY, US, 14831; Durham, NC, US, 27712; Tewksbury, MA, US, 01876

Company: Corning

Role Purpose

This 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 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 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 requirements
• Lead CSV projects of moderate scale and complexity
• Participate in and sometimes lead validation activities on larger‑scale system implementation or remediation projects
• Some travel is required as part of the job responsibilities

Experiences/Education - Required

• Bachelor’s degree in a technical or scientific field
• 1–2 years of experience in CSV, quality, IT systems, or regulated environments
• Working 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 readiness
• Exposure to systems such as ERP, LIMS, MES, SCADA, or eQMS
• Strong attention to detail and technical documentation skills
• Analytical thinker with problem‑solving and risk‑based decision‑making ability
• Effective communicator with strong collaboration skills
• Able to manage multiple tasks and work independently

Desired Experience & Skills

• Life Science or Pharmaceutical Packaging product application knowledge and experience
• Injection Molding manufacturing process knowledge and experience
• Certified Quality Engineer recognition by ASQ
• Certified Green or Black Belt recognition by ASQ

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.

Benefits

• Company‑wide bonuses and long‑term incentives aligned with key business results
• 100% company‑paid pension benefit with fixed contributions that grow throughout your career, and matching contributions to your 401(k) savings plan (up to 7-12% of pay)
• Health and wellness benefits including 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)
• 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].