Inc. (Vti)
CQV Engineer
Inc. (Vti), Los Angeles, California, United States, 90079
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 industries.
We are looking for a CQV Engineer with 5+ years of experience in Project Engineering and Validation for a 2-year 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. The estimated start date is the 2nd week in July.
RESPONSIBILITIES:
Project Engineering SupportUser Requirement SpecificationsFunctional SpecificationsDesign SpecificationsSOPsManagement of Change (MOC)Support FMEA activities.Support HAZOP processes.Perform Risk Assessments.Perform Gap Assessments.Project Closeout DocumentationTurnover Package GenerationProject Change RequestsSupport Client and A/E Firm in Project Design, Conceptual Design, Basic Design, Detailed Design and Design ReviewConstruction ActivitiesGenerate and Manage Safety Management Plans and DocumentationDisruptive Construction Activity RequestsJob Hazard AnalysisLockout Tag Out PlanHot Work PermittingPermit to WorkDetour PlansConstruction SignagePlant-wide Communications.Generate and Manage Quality Management Plans and DocumentationConstruction Control PlanManage Installation, Operational, and Performance QualificationSummary Report Training and DocumentationRisk Assessment and MitigationChange ControlQuality AuditsValidation SupportEquipment Installation Qualification,Operational Qualification and Performance QualificationProcess ValidationEquipment Cleaning ValidationFacility QualificationConduct validation of critical facility systemsSoftware Validationincluding data management and process control systems.Compile Validation ReportsQualifications:
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 activitiesExperience with pharmaceutical process equipment and instrumentation.Proficiency in Equipment, Process, Cleaning, Facility and Software ValidationExcellent problem-solving and troubleshooting skillsStrong leadership, project management and client management skillsProficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.Exceptional technical writing, review and analytical skills.Knowledge of good documentation practicesandcGMP.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
#J-18808-Ljbffr
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 industries.
We are looking for a CQV Engineer with 5+ years of experience in Project Engineering and Validation for a 2-year 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. The estimated start date is the 2nd week in July.
RESPONSIBILITIES:
Project Engineering SupportUser Requirement SpecificationsFunctional SpecificationsDesign SpecificationsSOPsManagement of Change (MOC)Support FMEA activities.Support HAZOP processes.Perform Risk Assessments.Perform Gap Assessments.Project Closeout DocumentationTurnover Package GenerationProject Change RequestsSupport Client and A/E Firm in Project Design, Conceptual Design, Basic Design, Detailed Design and Design ReviewConstruction ActivitiesGenerate and Manage Safety Management Plans and DocumentationDisruptive Construction Activity RequestsJob Hazard AnalysisLockout Tag Out PlanHot Work PermittingPermit to WorkDetour PlansConstruction SignagePlant-wide Communications.Generate and Manage Quality Management Plans and DocumentationConstruction Control PlanManage Installation, Operational, and Performance QualificationSummary Report Training and DocumentationRisk Assessment and MitigationChange ControlQuality AuditsValidation SupportEquipment Installation Qualification,Operational Qualification and Performance QualificationProcess ValidationEquipment Cleaning ValidationFacility QualificationConduct validation of critical facility systemsSoftware Validationincluding data management and process control systems.Compile Validation ReportsQualifications:
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 activitiesExperience with pharmaceutical process equipment and instrumentation.Proficiency in Equipment, Process, Cleaning, Facility and Software ValidationExcellent problem-solving and troubleshooting skillsStrong leadership, project management and client management skillsProficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.Exceptional technical writing, review and analytical skills.Knowledge of good documentation practicesandcGMP.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
#J-18808-Ljbffr