Validation Consultant

6 days ago


El Segundo, California, United States VTI Life Sciences Full time
About the Role

This is an exciting opportunity to join our team as a Validation Consultant and contribute to the success of a 2-year project at a pharmaceutical facility in the Greater Los Angeles area.

Key Accountabilities:
  • Develop and manage User Requirement Specifications for pharmaceutical process equipment and instrumentation.
  • Collaborate with cross-functional teams to create Functional Specifications for validation activities related to project expansion.
  • Prepare Design Specifications for construction and qualification of critical facility systems.
  • Develop and manage Standard Operating Procedures for validation and quality assurance activities.
  • Implement Management of Change processes to ensure regulatory compliance.
  • Conduct Failure Mode and Effects Analysis for risk assessment and mitigation.
  • Participate in Hazard and Operability studies to identify potential hazards.
  • Perform Risk Assessments to ensure a safe working environment.
  • Compile final project documentation for client handover.
  • Develop comprehensive turnover packages for clients.
Requirements:
  • Bachelor's degree or higher in Engineering, Life Sciences or a related discipline.
  • 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.
What We Offer:
  • $95,000 - $120,000 annual salary range for a W2 employee.
  • Competitive compensation package.
  • Excellent benefits.
  • 401K plan.
  • Professional development opportunities.
  • Stimulating and collaborative work environment.


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