Senior CQV & Packaging Engineer — Onsite (Thousand Oaks)

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) 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.