Equipment CQV Engineer

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

Job Description

• Seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility.
• Consultants will be responsible for hands-on execution of equipment commissioning and qualification activities, including reviewing and executing established qualification protocols, documenting test results, identifying and resolving execution issues, and supporting equipment readiness for manufacturing and engineering activities.
• The role will involve qualification of various manufacturing, laboratory, and support equipment in a regulated GMP environment.
• Candidates should be comfortable working independently, moving quickly through multiple equipment packages, and collaborating with Engineering, Validation, Manufacturing, Quality, and equipment vendors.

Qualifications

• Approximately 510 years of CQV, equipment validation, or equipment qualification experience.
• Strong hands-on experience executing IQ/OQ and other equipment qualification protocols.
• Pharmaceutical, biotechnology, biopharmaceutical, cell therapy, or other GMP-regulated manufacturing experience.
• Experience qualifying manufacturing and/or laboratory equipment.
• Ability to review protocols, execute testing, document results, and address discrepancies or deviations encountered during execution.
• Understanding of GMP documentation and good documentation practices.