CQV Engineer
Greater Los Angeles Area, CA
Contracted
Mid Level
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career 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 industry.
We are looking for two (2) CQV Engineers to support our LA area client's project. We are looking for CQV Engineers with Facilities CQV experience including EMPQ, Vessel IOV, and IOPQ, including mixing and temp mapping. Though our client has personnel assigned to Utilities (WFI, Alcohol, N2, Compressed Air, etc), CIP, Filter Press, Centrifuge, CIP skids, and Cleaning Validation, this experience is preferred in case our client needs additional support. The job also requires daily job walks of the construction site in full PPE.
The candidate must have experience in qualifying cleanroom facilities and large process equipment (vessels, centrifuges, filter presses, and CIP skids). They must have written and executed protocols and written a final report. The job is 100% on-site and requires daily walks of the job/ construction site.
PROJECT OVERVIEW
Generation and Modification of project lifecycle documentation for LA Plant Site.
o User Requirement Specifications
o Functional Specifications
o Design Specifications
o SOPs
o Management of Change (MOC)
o FMEA
o HAZOPs
o Risk Assessments
o Gap Assessments
Management of Project Change Control Records (PRs)
o Generate/Initiate
o Manage
o Close
Support Client and A/E Firm in Project Design
o Conceptual Design
o Basic Design
o Detailed Design
o Design Review
Construction Activities
o Generate and Manage Safety Management Plans and Documentation
o Disruptive Construction Activity Requests
o Job Hazard Analysis
o Lockout Tag Out Plan
o Hot Work Permitting
o Permit to Work
Manage Installation and Operational Commissioning
o Author and Approve
o Execution
o Function Testing
o Support site acceptance testing to review system documents and functions during SAT.
o Summary Report
Manage Installation, Operational, and Performance Qualification
o Author and approve.
o Develop and execute qualification protocols.
o Assist with any deviation resolution and handling.
o Execution
Summary Report Training and Documentation
o Train personnel on the operation of the Fractionation process, and related procedures
o Create comprehensive documentation of all validation activities.
Risk Assessment and Mitigation
o Identify and assess potential risks to product quality and patient safety.
o Develop mitigation strategies and contingency plans.
Change Control
o Manage change control for any modifications or updates to the equipment or processes.
Quality Audits
o Conduct internal and external audits to ensure compliance with quality standards and regulations.
Start-up support
o Start-up support for process equipment and facility as required.
VALIDATION SUPPORT - Responsibilities include (but are not limited) to the following:
Installation Qualification
o Equipment installation verification and confirmation that equipment is installed in accordance with the manufacturer's specifications
o Document equipment installation and location.
Operational Qualification
o Equipment functional verifications under operational conditions.
o Conduct testing of equipment functionality and performance.
o Documenting of all test results and deviations
Performance Qualification
o Confirmation of the fractionation performance
o Validate the manufacturing process and critical process parameters.
o Generate and review batch records and documentation.
Process Validation
o Conduct process validation studies to ensure consistent product quality.
o Perform risk assessments and implement process controls.
o Develop and validate analytical methods for product testing.
Cleaning Validation
o Validate the cleaning procedures for the equipment to prevent cross-contamination.
o Document cleaning validation protocols and results
Facility Qualification
o Conduct validation of critical facility systems
Software Validation
o Validate any software system used in the fractionation process, including data management and process control systems.
Validation Reports
o Compile validation reports summarizing all activities, results, and conclusions.
o Include recommendations for ongoing monitoring and maintenance
We are looking for two (2) CQV Engineers to support our LA area client's project. We are looking for CQV Engineers with Facilities CQV experience including EMPQ, Vessel IOV, and IOPQ, including mixing and temp mapping. Though our client has personnel assigned to Utilities (WFI, Alcohol, N2, Compressed Air, etc), CIP, Filter Press, Centrifuge, CIP skids, and Cleaning Validation, this experience is preferred in case our client needs additional support. The job also requires daily job walks of the construction site in full PPE.
The candidate must have experience in qualifying cleanroom facilities and large process equipment (vessels, centrifuges, filter presses, and CIP skids). They must have written and executed protocols and written a final report. The job is 100% on-site and requires daily walks of the job/ construction site.
PROJECT OVERVIEW
- Start: May 2025
- Level of Experience: 1 - 4 years
- Length of Contract: 12 months
- 40 hours per week (Monday-Friday)
- This position is 100% onsite & the candidate needs to reside locally to commute to LA site
Generation and Modification of project lifecycle documentation for LA Plant Site.
o User Requirement Specifications
o Functional Specifications
o Design Specifications
o SOPs
o Management of Change (MOC)
o FMEA
o HAZOPs
o Risk Assessments
o Gap Assessments
Management of Project Change Control Records (PRs)
o Generate/Initiate
o Manage
o Close
Support Client and A/E Firm in Project Design
o Conceptual Design
o Basic Design
o Detailed Design
o Design Review
Construction Activities
o Generate and Manage Safety Management Plans and Documentation
o Disruptive Construction Activity Requests
o Job Hazard Analysis
o Lockout Tag Out Plan
o Hot Work Permitting
o Permit to Work
Manage Installation and Operational Commissioning
o Author and Approve
o Execution
o Function Testing
o Support site acceptance testing to review system documents and functions during SAT.
o Summary Report
Manage Installation, Operational, and Performance Qualification
o Author and approve.
o Develop and execute qualification protocols.
o Assist with any deviation resolution and handling.
o Execution
Summary Report Training and Documentation
o Train personnel on the operation of the Fractionation process, and related procedures
o Create comprehensive documentation of all validation activities.
Risk Assessment and Mitigation
o Identify and assess potential risks to product quality and patient safety.
o Develop mitigation strategies and contingency plans.
Change Control
o Manage change control for any modifications or updates to the equipment or processes.
Quality Audits
o Conduct internal and external audits to ensure compliance with quality standards and regulations.
Start-up support
o Start-up support for process equipment and facility as required.
VALIDATION SUPPORT - Responsibilities include (but are not limited) to the following:
Installation Qualification
o Equipment installation verification and confirmation that equipment is installed in accordance with the manufacturer's specifications
o Document equipment installation and location.
Operational Qualification
o Equipment functional verifications under operational conditions.
o Conduct testing of equipment functionality and performance.
o Documenting of all test results and deviations
Performance Qualification
o Confirmation of the fractionation performance
o Validate the manufacturing process and critical process parameters.
o Generate and review batch records and documentation.
Process Validation
o Conduct process validation studies to ensure consistent product quality.
o Perform risk assessments and implement process controls.
o Develop and validate analytical methods for product testing.
Cleaning Validation
o Validate the cleaning procedures for the equipment to prevent cross-contamination.
o Document cleaning validation protocols and results
Facility Qualification
o Conduct validation of critical facility systems
Software Validation
o Validate any software system used in the fractionation process, including data management and process control systems.
Validation Reports
o Compile validation reports summarizing all activities, results, and conclusions.
o Include recommendations for ongoing monitoring and maintenance
HOURLY PAY RATE RANGE FOR THIS ROLE IS $60 - $70 PER HOUR
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, a matching 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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