Equipment CQV Engineer

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 180,000; 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. Consultants will perform hands-on commissioning and qualification activities, review protocols, document results, and help ensure equipment readiness for manufacturing and engineering activities.

The role covers qualification of manufacturing, laboratory, and support equipment in a regulated GMP environment.

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 and document test results.
• Identify and resolve execution issues and support equipment readiness for manufacturing and engineering activities.
• Collaborate with Engineering, Validation, Manufacturing, Quality, and equipment vendors.

Skills

CQV experience

IQ/OQ execution

GMP documentation practices

Independent working

Tools

IQ/OQ protocols

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.

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.