Senior Validation Engineer

2 weeks ago


Los Angeles, California, United States VTI Life Sciences Full time
Job Title: CQV Engineer

We are seeking a highly skilled and experienced CQV Engineer to join our team at VTI Life Sciences. As a CQV Engineer, you will be responsible for supporting our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries.

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

We offer competitive compensation, excellent benefits, 401K, and a stimulating and collaborative work environment. If you are a motivated and experienced professional looking to accelerate your career in the pharmaceutical, biotechnology and medical device industries, we encourage you to apply for this exciting opportunity.



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