Sr CQV and Packaging Engineer - Thousand Oaks, CA

validationtechnologiesinc; Thousand Oaks (CA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Professional development

Training

Competitive compensation

Excellent benefits

401K matching

Job summary

VTI Life Sciences (VTI) in Thousand Oaks, CA seeks a seasoned CQV lead to accelerate validation projects in pharmaceutical and biotech environments. You will develop and execute CQV protocols, manage risk assessments, and coordinate with Manufacturing and QA to ensure compliant, timely execution.

Ideal candidates bring 7+ years in biotech/pharma validation, strong technical writing, and experience with packaging validation and regulatory guidelines.

Qualifications

• Bachelor’s degree or higher in Engineering, Chemistry, Pharmaceutical Sciences or related field.
• Minimum 7+ years of experience in Biotechnology or Pharmaceutical industries.
• Minimum 3+ years in Packaging Validation including filling and capping, isolators, drop tests, stress tests, packaging systems.
• Strong technical writing and protocol/report development skills.
• Ability to interpret complex data and resolve validation issues.
• Effective English communication and cross-functional collaboration.

Responsibilities

• Develop and execute CQV protocols, reports, and risk assessments per 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

Technical writing

Protocol development

Data interpretation

Communication skills

Cross-functional collaboration

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.

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