Validation Engineer II: GMP Compliance & Quality Assurance

Grow in Greenville, NC

Greenville (NC)

On-site

USD 85,000 - 100,000

Full time

2 days ago
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Job summary

Thermo Fisher Scientific in Greenville, NC is seeking a Talent Engineer II, Validation. You will join a global team and contribute to validation activities ensuring compliance, quality, and operational excellence across facilities in pharmaceutical manufacturing, lab operations, and quality control.

You will apply IQ/OQ/PQ protocols, manage validation projects independently, and work with automation systems. Strong technical writing, risk assessment, and communication skills are essential.

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field.
  • 2 years of validation experience in a GMP/regulated environment preferred.
  • Experience with IQ/OQ/PQ protocols and execution.
  • Experience managing validation projects independently.
  • Experience with automation systems and computer system validation.
  • Experience with quality management systems and documentation.

Responsibilities

  • Conduct validation activities to ensure compliance and quality across facilities.
  • Support GMP/regulatory compliance in pharmaceutical manufacturing and labs.
  • Collaborate with cross-functional teams on validation projects and documentation.
  • Maintain quality systems and ensure timely completion of validation milestones.

Skills

cGMP knowledge
FDA regulations
Technical writing
Risk assessment
Data analysis
Communication
Project management
Metrology

Education

Bachelor's degree in Engineering or Life Sciences
Advanced degree preferred

Tools

Automation systems
Computer system validation
Microsoft Office

Job description

Thermo Fisher Scientific in Greenville, NC is seeking a Talent Engineer II, Validation. You will join a global team and contribute to validation activities ensuring compliance, quality, and operational excellence across facilities in pharmaceutical manufacturing, lab operations, and quality control.

You will apply IQ/OQ/PQ protocols, manage validation projects independently, and work with automation systems. Strong technical writing, risk assessment, and communication skills are essential.

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