Senior CSV Engineer: Automation & Compliance Lead

ThermoFisher Scientific; Greenville (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Thermo Fisher Scientific in North Carolina seeks a Validation Engineer III (Computer Systems Validation - CSV) to drive qualification strategies across pharmaceutical manufacturing lines. You’ll lead validation activities for equipment, processes, utilities and computer systems, focusing on CSV and change management.

You will collaborate with automation, manufacturing and quality teams, prepare IQ/OQ/PQ protocols, and support regulatory inspections.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field.
• Minimum 4 years of validation experience in pharma/biotech or regulated industry.
• Strong knowledge of cGMP regulations (FDA, EMA, ISO).
• Experience with CSV, CQV, or automation validation.
• Experience writing and executing IQ/OQ/PQ protocols.
• Experience with automation and control systems (PLC, SCADA, DCS, DeltaV, Allen-Bradley).
• Proven ability to lead validation projects and cross-functional teams.
• Excellent technical writing and documentation skills.
• Experience with risk assessment methodologies and statistical analysis.

Responsibilities

• Lead validation activities for equipment, processes, utilities, and computer systems, with emphasis on CSV.
• Evaluate and support change management for existing manufacturing systems and automation platforms.
• Author, review, and execute validation documentation including IQ/OQ/PQ protocols and qualification plans.
• Perform and lead risk assessments, gap analyses, and validation assessments.
• Collaborate with automation engineers on systems such as PLC, SCADA, DCS, DeltaV, and Allen-Bradley platforms.
• Independently manage validation projects and coordinate cross-functional teams.
• Provide technical expertise during regulatory inspections and client audits.
• Mentor junior team members and support knowledge sharing across the team.
• Contribute to continuous improvement and operational excellence initiatives.

Education

Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field

Tools

PLC

SCADA

DCS

DeltaV

Allen-Bradley

Job description

Thermo Fisher Scientific in North Carolina seeks a Validation Engineer III (Computer Systems Validation - CSV) to drive qualification strategies across pharmaceutical manufacturing lines. You’ll lead validation activities for equipment, processes, utilities and computer systems, focusing on CSV and change management.

You will collaborate with automation, manufacturing and quality teams, prepare IQ/OQ/PQ protocols, and support regulatory inspections.