What are the responsibilities and job description for the CQV Engineer position at Tekhawks LLC?
Title: CQV EngineerDuration : 12 Months Location: Los Angeles, CA A large pharmaceutical company in Los Angeles is in immediate need of a CQV Engineer for a 12-month project, this is an onsite position and is 40 hours/week. The client needs someone with Facilities CQV experience including EMPQ (environmental monitoring performance qualification), Vessel IQ/OQ/PQ including mixing and temp mapping. They have 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 they need additional support. The project also requires daily job walks of the construction site daily in full PPE.Top Requirements:BS degree minimum3-10 years of Validation Engineering experience in pharmaceutical industryStrong skill set in installation and IQOQ of equipment like centrifuges, filter presses, and processing tanks (must be on CV)Cleanroom qualification experience is a plusVery strong technical writing/documentation skillsVery strong communication skills and ability to coordinate with cross-functional teamsExperience doing job walks with engineers for capital projectsMust have a positive attitude and ability to multi-taskMust be committed to supporting a long-term project that could go for 2 yearsMust be available to support other shifts as requested by the client, this could happen on short notice Full Scope of Project- DO NOT NEED EXPERIENCE IN ALL:Generation and Modification of project lifecycle documentation for LA Plant Site.User Requirement SpecificationsFunctional SpecificationsDesign SpecificationsSOPsManagement of Change (MOC)FMEAHAZOPsRisk AssessmentsGap AssessmentsProject Closeout DocumentationTurnover Package GenerationProject Change RequestsConstruction 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 PlanAssist in site supervision of construction personnel.Manage Installation and Operational CommissioningAuthor and ApproveExecutionFunction TestingBOM UpdatesPM GenerationAsset LifecycleDrawing UpdatesSupport site acceptance testing to review system documents and functions during SAT.Summary ReportManage Installation, Operational, and Performance QualificationAuthor and approve.Develop and execute qualification protocols.Assist with any deviation resolution and handling execution.Summary Report Training and DocumentationTrain personnel on the operation of the Fractionation process, and related proceduresCreate comprehensive documentation of all validation activities.Risk Assessment and MitigationIdentify and assess potential risks to product quality and patient safety.Develop mitigation strategies and contingency plans.Change ControlManage change control for any modifications or updates to the equipment or processes.Quality AuditsConduct internal and external audits to ensure compliance with quality standards and regulations.Start up support.Start up support for process equipment and facility as required.Installation QualificationEquipment installation verification and confirmation that equipment is installed inAccordance with manufacturer's specifications.Document equipment installation and location.Operational QualificationEquipment functional verifications under operational conditions.Conduct testing of equipment functionality and performance.Documenting of all test results and deviationsPerformance QualificationConfirmation of the fractionation performanceValidate the manufacturing process and critical process parameters.Generate and review batch records and documentation.Process ValidationConduct process validation studies to ensure consistent product quality.Perform risk assessments and implement process controls.Develop and validate analytical methods for product testing.Cleaning ValidationValidate the cleaning procedures for the equipment to prevent cross contamination.Document cleaning validation protocols and results.Facility QualificationConduct validation of critical facility systemsSoftware ValidationValidate any software system used in the fractionation process, including data management and process control systems.Validation ReportsCompile validation reports summarizing all activities, results, and conclusions.Include recommendations for ongoing monitoring and maintenance.
Salary : $38 - $42