CQV Engineers​/Specialists

VTI Life Sciences (VTI) is seeking forward‑thinking and ambitious engineers to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries.

We are looking for multiple CQV Engineers with 5+ years of experience in project engineering and validation for a long‑term project to support engineering and CQV activities at our client’s pharmaceutical facility in the Greater Los Angeles area.

• User Requirement Specifications
• Functional Specifications
• Design Specifications
• SOPs
• Management of Change (MOC)
• Support FMEA activities
• Support HAZOP processes
• Perform Risk Assessments
• Perform Gap Assessments
• Project Closeout Documentation
• Turnover Package Generation
• Project Change Requests
• Support Client and A/E Firm in Project Design, Conceptual Design, Basic Design, Detailed Design and Design Review

• Generate and Manage Safety Management Plans and Documentation
• Disruptive Construction Activity Requests
• Job Hazard Analysis
• Lockout Tag Out Plan
• Hot Work Permitting
• Permit to Work
• Detour Plans
• Construction Signage
• Plant-wide Communications
• Generate and Manage Quality Management Plans and Documentation
• Construction Control Plan
• Manage Installation, Operational, and Performance Qualification
• Summary Report Training and Documentation
• Risk Assessment and Mitigation
• Change Control
• Quality Audits

• Equipment Installation Qualification, Operational Qualification and Performance Qualification
• Process Validation
• Equipment Cleaning Validation
• Facility Qualification
• Conduct validation of critical facility systems
• Software Validation including data management and process control systems
• Compile Validation Reports

• Bachelor’s degree or higher in Engineering, Life Sciences, or related discipline (Mechanical Eng., Chemical Eng., Chemistry, Biology, etc.)
• 5+ years of relevant FDA‑regulated industry experience
• Must be local to the LA area (travel expenses are not allowed)
• Knowledge of cGMP and other regulatory standards
• Proficiency in Project Engineering and construction‑related activities
• Experience with pharmaceutical process equipment and instrumentation
• Proficiency in Equipment, Process, Cleaning, Facility and Software Validation
• Excellent problem‑solving and troubleshooting skills
• Strong leadership, project management and client management skills
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
• Exceptional technical writing, review and analytical skills
• Knowledge of good documentation practices and cGMP

$95,000 – $120,000 annually for a W2 employee.

VTI Life Sciences offers professional development, training, competitive compensation, excellent benefits, 401(k) and a stimulating and collaborative work environment. We provide opportunities for exciting career growth in a culture that values trust, respect, openness, teamwork, creativity, enthusiasm and diligence.

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities, and we measure progress toward this goal every five years.