CQV Engineers/Specialists - Los Angeles Area, CA
1 day ago
Job summary
We are looking for multiple CQV Engineers with 5+ years of experience in Project Engineering and Validation for a long-term 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.We are seeking experienced validation Engineers/Specialists with a wide range of experience to fill the multiple roles. Responsibilities include: 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 Performance Qualification Equipment Installation Qualification Operational Qualification Performance Qualification Process Validation Equipment Cleaning Validation Facility Qualification Conduct validation of critical facility systems Software Validation including data management 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 . Years relevant FDA-regulated industry experience Candidates must be local LA area as travel expenses not allowed Knowledge cGMP regulatory standards Proficiency Project Engineering construction-related activities Experience pharmaceutical process equipment instrumentation Proficiency Equipment Process Cleaning Facility Software Validations Excellent problem-solving troubleshooting skills Strong leadership project management client management skills Proficiency Microsoft Office Word Excel PowerPoint MS Visio etc Exceptional technical writing review analytical skills Knowledge good documentation practices cGMP valid_jobJob description
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