Senior CQV & Packaging Validation Engineer (Onsite)

Inc. (Vti); Thousand Oaks (CA); On-site; USD 120,000 - 190,000; Full time

Job summary

VTI Life Sciences is seeking a Senior CQV Engineer to support a client project in Thousand Oaks, CA. The role focuses on developing, executing, and reporting CQV protocols (IQ, OQ, PQ) for utility, HVAC, filling, and packaging systems.

This is a 6-month, full-time, onsite assignment requiring at least 7 years of CQV experience in biotech/pharma. Ideal candidates possess strong technical writing, qualification development, and cross-functional collaboration with Manufacturing and QA.

Qualifications

• Minimum 7+ years of experience in Biotechnology or Pharmaceutical industries.
• Minimum 3+ years of experience in Packaging Validation including filling and capping processes, isolators, drop tests, and packaging systems.
• Strong technical writing and protocol/report development skills.
• Effective English native communication and cross-functional collaboration skills.

Responsibilities

• Develop and execute CQV protocols, reports, and risk assessments in line with client procedures and regulatory guidelines (cGMP, FDA, EMA).
• Coordinate validation activities with Manufacturing and QA to ensure proper execution.
• Investigate and resolve protocol deviations and nonconformities.
• Support change control activities related to system and equipment modifications.
• Write and maintain SOPs for system and equipment operation and maintenance.
• Ensure documentation meets internal quality standards and audit readiness.

Skills

CQV experience

Technical writing

Protocol/report development

Cross-functional collaboration

Independent lead contributor

Validation lifecycle management

Education

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

Tools

TrackWise

Kneat

Veeva

Job description

VTI Life Sciences is seeking a Senior CQV Engineer to support a client project in Thousand Oaks, CA. The role focuses on developing, executing, and reporting CQV protocols (IQ, OQ, PQ) for utility, HVAC, filling, and packaging systems.

This is a 6-month, full-time, onsite assignment requiring at least 7 years of CQV experience in biotech/pharma. Ideal candidates possess strong technical writing, qualification development, and cross-functional collaboration with Manufacturing and QA.