Inc. (Vti)
CQV Engineers/Specialists - Open Applications
Inc. (Vti), California, Missouri, United States, 65018
CQV Engineers/Specialists - Open Applications
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 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
Permit to Work
Detour Plans
Construction Signage
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. We offer 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.
What\'s your citizenship / employment eligibility?
The following questions are optional. To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we may request that you enter this personal data. This information will not be used in connection with any employment decisions.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
A “disabled veteran” is one of the following: a veteran entitled to compensation or a service-connected disability.
A “recently separated veteran” means any veteran during the three-year period following discharge.
An “active duty wartime or campaign badge veteran” means service during a war or campaign for which a badge is authorized.
An “Armed forces service medal veteran” means participation in a qualifying operation.
I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE I AM NOT A PROTECTED VETERAN I DON’T WISH TO ANSWER
Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities.
Public burden statement and disability information are included for compliance purposes only.
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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 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
Permit to Work
Detour Plans
Construction Signage
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. We offer 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.
What\'s your citizenship / employment eligibility?
The following questions are optional. To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we may request that you enter this personal data. This information will not be used in connection with any employment decisions.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
A “disabled veteran” is one of the following: a veteran entitled to compensation or a service-connected disability.
A “recently separated veteran” means any veteran during the three-year period following discharge.
An “active duty wartime or campaign badge veteran” means service during a war or campaign for which a badge is authorized.
An “Armed forces service medal veteran” means participation in a qualifying operation.
I IDENTIFY AS ONE OR MORE OF THE CLASSIFICATIONS OF PROTECTED VETERAN LISTED ABOVE I AM NOT A PROTECTED VETERAN I DON’T WISH TO ANSWER
Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities.
Public burden statement and disability information are included for compliance purposes only.
#J-18808-Ljbffr