CQV Engineer

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career 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 industries.
We are looking for a CQV Engineer with 5+ years of experience in Project Engineering and Validation for a 2-year project to help support Engineering and CQV activities related to the project expansion at our client's pharmaceutical facility in the Greater Los Angeles area. The estimated start date is the 2nd week in July.
RESPONSIBILITIES:
Project Engineering Support

• 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

Construction Activities

• 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

Validation Support

• 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

Qualifications:

• 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.
• 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.

SALARY RANGE FOR THIS ROLE IS $95,000 - $120,000 ANNUALLY FOR A W2 EMPLOYEE
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, 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