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VTI Life Sciences ยท 2 days ago
CQV Engineer
Greater Los Angeles, CA
Full-time
Onsite
Senior Level
$95K/yr - $120K/yr
5+ years exp
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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 Support 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
Qualification
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Required
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
Benefits
401K
Professional development
Training
Competitive compensation
Excellent benefits
Company
VTI Life Sciences
VTI Life Sciences is an ISO 9001:2000 Certified Company with the experience, expertise, and commitment to provide the superior service required to meet all of your validation and compliance needs.
51-200 employees
H1B Sponsorship
VTI Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (18)
2022 (29)
2021 (28)
2020 (69)
Funding
Current Stage
Growth StageCompany data provided by crunchbase
