Validation Engineer II #: 21-00644

Company: HireTalent Executive Search, Temporary Staffing, R
Location: Oceanside
Posted on: February 18, 2021

Job Description:

Job DescriptionJob Title: Validation Engineer IIJob Location: Oceanside, CAJob Duration: 10 monthsDutiesGeneral Commissioning, Qualification and Validation (CQV).Oversight of Change Records, which includes CR generation through tracking CR closure. CR's are for automation, facilities, utilities and process.Prepare/ Author Qualification and Commissioning Protocols.Perform Testing, collects samples, analyzing test results, and prepares Commissioning and Qualification summary reports.Plan, perform and coordinate Installation Qualification (IQ), inclusive of test generation and execution.Peer Reviews Validation Protocols, Commissioning Test and Design documents.Provide technical assessment and validation review/ approval for engineering, process and standard operating procedure changes.Prepare Risk Management Reports documenting system risks, applicable remediation/ risk reduction and critical controls.Provide input and continuous improvement recommendations to commissioning / qualification protocols.Manage development of accurate completion of all commissioning and qualification documentation and Engineering TOPs to ensure that such documents are properly documented and complete.Incorporate commissioning protocol execution with process testing and debugging activities.Participate in FAT, and manage SAT executions.Accountable For Project-specificDesign QualificationSystem Impact Assessments (SIA's)Criticality Assessment (CA's)Risk Assessment (RA's)Requirements Trace Matrices (RTM's)Design VerificationCommissioning and Commissioning Test documentationInstrument Calibration assessmentsOperational Qualification and Process Qualification 1 (process support systems) documentation creation, execution and summary reportsProvide C&Q Support And Updates ForUser Requirements Specifications (URS)Functional Specifications (FS)Automation Functional Requirements (AFR)Functional Batch Record Review (FBRR)Support validation planning and execution efforts.Ability to successfully resolve and close Punch List itemsProject closeout activities.Attend any project specific meetings as assigned.Any additional activities, deliverables requested by Project Manager (or his designee)Maintain all required training to ensure job responsibilities can be performed on a daily basis.Vigilant to safety and maintains a safe environment for all during performance of job responsibilities (i.e. Validation Field Execution).Skills* 3-6 years of direct GMP/ validation experience with increasing levels of responsibility for protocol generation, execution and planning of wide range of validation equipment and software.* Experience with Emerson DeltaV, Emerson Syncade and Pi software preferred.* Proficient/ thorough knowledge of validation of principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectation and industry trends.* Strong technical writing, verbal communication, interpersonal and problem solving skills.* Ability to work independently.* Strong computer skills and familiarity with Microsoft office suite programs.* Excellent collaboration and ability to communicate information to a varied audience.* Compliance to cGMP requirements.* Demonstrate good record keeping practices and attention to detail.

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