CQV Engineer

2 weeks ago

Los Angeles, United States Intellectt Inc Full time

Hi,

Hope you are doing well.

This is Alekhya from Intellectt INC; we have an immediate opportunity with one of our clients. Please find the below job description and if you are interested, please forward your resume to alekhya@intellectt.com


Role: CQV Engineer

Location: Los Angles, CA

Duration: 12+ Months Contract


Job Description:

We are seeking an experienced CQV Engineer with 1-4 years of experience in Project Engineering and Validation for a 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.


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.

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