CSV Quality Engineer I - Life Sciences Compliance

Corning Incorporated

City of Corning (NY)

On-site

USD 67,000 - 92,000

Full time

2 days ago

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Benefits offered by this job

Bonuses and incentives

401(k) matching

Comprehensive benefits

Job summary

Corning Incorporated is seeking a CSV Specialist to ensure GxP computerized systems remain compliant, validated, and fit for use across Life Sciences operations. You will support system validation, implementation, maintenance, and data integrity through risk-based approaches while partnering with IT, Automation, Quality, Engineering, and system owners.

The role requires a Bachelor’s degree in a technical or scientific field and 1–2 years of experience in CSV or regulated environments.

Qualifications

Bachelor’s degree in a technical or scientific field.
1–2 years of experience in CSV, quality, IT systems, or regulated environments.
Familiarity with GxP and validation lifecycle (IQ/OQ/PQ) and ALCOA+ data integrity.

Responsibilities

Standardize CSV procedures, templates, and documentation across division manufacturing and laboratory facilities.
Implement and maintain 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.
Manage validation state and lifecycle through risk-based approaches and regulatory expectations.
Support data integrity, electronic records, electronic signatures, and audit trails compliance.
Collaborate with IT, Quality, Engineering, and system owners on validation activities and deployments.
Assist in supplier qualification activities for software vendors and third-party integrators.
Participate in audits and inspections and prepare for inspection readiness.
Lead moderate-scale CSV projects and assist larger implementations.