Senior CQV Engineer: Packaging & Utilities (Onsite CA)

VTI Life Sciences; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

VTI Life Sciences in Thousand Oaks, CA seeks a Senior CQV Engineer to lead CQV activities for client validation projects in pharma/biotech. You will develop, execute, and report IQ/OQ/PQ protocols for utilities, HVAC, filling, and packaging systems onsite.

The role requires 7+ years of CQV experience, strong technical writing, and cross-functional collaboration. You will work with TrackWise/Kneat/Veeva and ensure compliance with cGMP, FDA, and EMA guidelines.

Qualifications

• 7+ years of CQV experience in pharma/biotech industries.
• Strong ability to develop, execute, and report CQV protocols (IQ/OQ/PQ).
• Experience with validation lifecycle management systems.

Responsibilities

• Develop and execute CQV protocols, reports, and risk assessments per regulatory guidelines.
• Coordinate validation activities with Manufacturing and QA.
• Investigate and resolve protocol deviations and nonconformities.
• Support change control activities for system/equipment modifications.
• Write and maintain SOPs for system and equipment operation and maintenance.
• Ensure audit readiness and documentation quality.

Skills

CQV experience

Technical writing

Cross-functional collaboration

English communication

Education

Bachelor’s degree or higher in Engineering/Chemistry/Pharmaceutical Sciences

Tools

TrackWise

Kneat

Veeva

Job description

VTI Life Sciences in Thousand Oaks, CA seeks a Senior CQV Engineer to lead CQV activities for client validation projects in pharma/biotech. You will develop, execute, and report IQ/OQ/PQ protocols for utilities, HVAC, filling, and packaging systems onsite.

The role requires 7+ years of CQV experience, strong technical writing, and cross-functional collaboration. You will work with TrackWise/Kneat/Veeva and ensure compliance with cGMP, FDA, and EMA guidelines.