Division Quality Engineer I

Corning•Tewksbury, MA

5d•$67,237 - $92,451•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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.

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
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