Sr CQV and Packaging Engineer - Thousand Oaks, 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 (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

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 Sciencesstrives 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.VTIoffers 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,VTIis 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