CQV Engineers/Specialists - Open Applications
About The Position
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries. 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. Our client is seeking experienced validation Engineers/Specialists with a wide range of experience to fill the multiple roles.
Requirements
- 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.
- Candidates must be local to the LA area as travel expenses are not allowed.
- 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.
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
Benefits
- VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment.
- We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
51-100 employees
