Sr CQV and Packaging Engineer - Thousand Oaks, CA

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 (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.

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.

PROJECT OVERVIEW

• Start: June/July2026
• Level of Experience: minimum 7+years of CQV experience in the pharmaceutical/biotechnology industries
• Length of Project: Approximately 6months
• 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

• Be an effective and independent, seasoned leadcontributor that requires minimal to no supervision and delivers results.
• 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 experiencein Packaging Validation including filling and capping process, isolators, drop test, stress test andpackaging systems.
• Strong technical writing and protocol/report development skills.
• Ability to interpret complex data and resolve validation issues.
• Effective english-native communication and cross-functional collaboration skills.
• Proficiency with validation lifecycle management systems and quality management systems (TrackWise, Kneat, Veeva, etc., a plus).

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation, and Validation Services to the Pharmaceutical, Biotechnology, Biologics, and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm, and diligence.

As one of the leading global Commissioning, Qualification, and Validation Services organizations, VTI is always looking for innovative, talented, and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org