VTI Life Sciences
CQV Engineers/Specialists - Open Applications
VTI Life Sciences, Los Angeles, California, United States, 90079
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.
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
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.
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.
SALARY RANGE FOR THIS ROLE IS $95,000 - $120,000 ANNUALLY FOR A W2 EMPLOYEE
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org
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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.
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
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.
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.
SALARY RANGE FOR THIS ROLE IS $95,000 - $120,000 ANNUALLY FOR A W2 EMPLOYEE
VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, 401K plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.
As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org
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