Engineer II, Computer Systems Validation - GMP & Automation

Regulatory Jobs

Greenville (NC)

On-site

USD 90,000 - 120,000

Full time

14 days+

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Job summary

Thermo Fisher Scientific in Greenville, NC seeks an Engineer II, Computer Systems Validation (CSV) to support validation of automation systems, manufacturing equipment, and computerized systems. You will focus on change management, qualification activities, and maintaining regulatory compliance while partnering with automation, manufacturing, and quality teams.

The role requires a Bachelor’s in Engineering or related field and about 2 years in validation or GMP environments.

Qualifications

Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related field.
Approximately 2 years of validation, CSV, or GMP-regulated experience.
Internship, co‑op, or academic project experience in validation, automation, or regulated industries will also be considered

Responsibilities

Evaluate changes to existing manufacturing systems, equipment, and related databases.
Support change management activities for commercial production lines.
Author and execute validation documentation including IQ/OQ/PQ protocols and qualification plans.
Perform risk assessments, validation assessments, and gap analyses to determine testing requirements.
Collaborate with automation and engineering teams to qualify system changes.
Support validation of automation and control systems (PLC, SCADA, DCS, DeltaV, etc.).
Ensure compliance with cGMP, FDA, and industry standards.
Maintain accurate and compliant validation documentation.
Participate in continuous improvement and operational excellence initiatives.