Full Job Description
We are looking for a Senior CQV Engineer to support a VTI client project in Thousand Oaks, CA. We need a Sr. CQV Engineer with experience developing, executing, and reporting CQV protocols (IQ, OQ, PQ) for utility, HVAC, filling, and packaging systems.
HOURLY PAY RATE RANGE FOR THIS ROLE IS $90,000 - $120,000 ANNUALLY AS A W2
PROJECT OVERVIEW
• Start: June/July 2026
• Level of Experience: minimum 7+ years of CQV experience in the pharmaceutical/biotechnology industries
• Length of Project: Approximately 12 months
• 40 hours per week (Monday-Friday)
• This position is 100% onsite & the candidate needs to reside locally to commute to the Thousand Oaks client site
Responsibilities
• Develop and execute CQV protocols, reports, and risk assessments in accordance with client procedures and cGMP, FDA, EMA, and other regulatory guidelines.
• Coordinate validation activities with Manufacturing and QA to ensure proper execution.
• Investigate and support the resolution of protocol deviations and nonconformities.
• Support change control activities related to system and equipment modifications.
• Write and maintain SOPs related to system and equipment operation and maintenance.
• Ensure documentation meets internal quality standards and audit readiness.
Requirements
• Bachelor's degree or higher in Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field.
• Minimum 7+ years of experience in the Biotechnology or Pharmaceutical industries
• Minimum 3+ years of experience in Packaging Validation including filling and capping process, isolators, drop test, stress test and packaging systems.
• Strong technical writing and protocol/report development skills.
• Ability to interpret complex data and resolve validation issues.
• Effective communication and cross-functional collaboration skills.
• Proficiency with validation lifecycle management systems and quality management systems (TrackWise, Kneat, Veeva, etc., a plus).