GMP Equipment CQV Engineer - Onsite Validation Expert

Katalyst CRO; Knoxville (TN); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. You will perform hands-on commissioning and qualification, review and execute protocols, document results, resolve issues, and ensure equipment readiness for manufacturing and engineering activities in a regulated GMP environment.

Candidates should collaborate with Engineering, Validation, Manufacturing, Quality, and equipment

Qualifications

• 5–10 years of CQV or equipment qualification experience.
• Hands-on IQ/OQ testing and documentation.
• GMP-regulated manufacturing experience.

Responsibilities

• Execute equipment qualification activities on site.
• Review and execute qualification protocols.
• Document test results and address discrepancies.
• Support equipment readiness for manufacturing and engineering activities.

Skills

CQV experience

IQ/OQ execution

GMP documentation

Job description

Katalyst CRO is seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. You will perform hands-on commissioning and qualification, review and execute protocols, document results, resolve issues, and ensure equipment readiness for manufacturing and engineering activities in a regulated GMP environment.

Candidates should collaborate with Engineering, Validation, Manufacturing, Quality, and equipment