Equipment CQV Engineer

Katalyst-Healthcares-; Knoxville (TN); On-site; USD 95,000 - 125,000; Full time

Job summary

Creative Solutions Services, LLC is seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. You will perform hands-on equipment commissioning and qualification, review protocols, document results, and resolve deviations to ensure readiness for manufacturing and engineering activities.

Candidates should have 5-10 years of CQV or related qualification experience, with strong IQ/OQ skills and GMP-regulated

Qualifications

• Approximately 5-10 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.

Responsibilities

• Hands-on execution of equipment commissioning and qualification activities.
• Review and execute established qualification protocols, document test results, and resolve issues.
• Qualify various manufacturing, laboratory, and support equipment in a GMP environment.
• Collaborate with Engineering, Validation, Manufacturing, Quality, and equipment vendors to ensure readiness.

Skills

CQV experience

IQ/OQ execution

GMP environment

Documentation

Equipment qualification

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 5-10 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.