Computer System Validation Engineer

General Purpose: Maintains quality engineering programs, standards and improvements within the organization.Principle Accountabilities:Defines the validation strategy for the V&V ProgramSupport to complete all the required CSV deliverablesEnsures and coordinates the proper execution of all Software V&V activitiesProvides an independent review and approve all the CSV deliverables generated during the Software V&VResponsible to conduct assessments such as Validation Applicability, 21CFRPart11 and Software Functionality Risk Assessment for all software’s listed in the IT ArchitectureReviews test case with trace matrix and ensures adequate test coverage in order to challenge the functionality and to determine if the proposed testing would achieve the purposeReviews executed protocols and reports for adherence to good record keeping practices and validation practices, and to determine if the conclusions drawn from the reports are justifiedProvides guidance on how to manage incident/defect handlingSupports to identify and forecast the risk and issue with an appropriate solutionProvide training to the stakeholders and new members in the team on Software Quality aspects and ensures the GDP training records are up to dateReview and update SOP’s and templates to align with regulatory requirementsProvide internal and external audit supportDevelops and initiates standards and methods for inspection, testing and evaluationDevises sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability dataDevelops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibilityDirects workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliabilityCompiles and writes training material and conducts training sessions on quality control activitiesSupports Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issuesAssures data availability and integrity for all quality related data. Consolidates and reports quality resultsInitiates corrective action requests as needed and tracks to satisfactory completionAssists with development and implementation of quality auditsResponsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished productsDesigns and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipmentAnalyzes reports and returned products and recommends corrective actionEstablishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilitiesApproves product, process and equipment qualificationsProvides liaison to various regulatory bodiesAfter you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Advantage TechnicalWith company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing – delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.