Computer System Validation Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.Company: One of Our ClientsJob Description:Job Title: CSV EngineerLocations: Portsmouth NH 03801Duration: 09+ months (Extendable)Pay Rate: $80.00 - 90.00/hr on W2Summaryassess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance.The CSV Provide a brief (3 – 4 Specialist Level 4 will risk assess systems, review change requests and sentence) description that states “why” the job exists test scripts, draft protocols and initiate and review GMP documentation and describes the nature revisions and level of work.Specialist will be involved as the QA CSV representative during small and large-scale projects.Job Description* • Perform all aspects of QMS process’ – Change Control, Deviations, CAPAs(Key Accountabilities)• Execute all responsibilities as CSV project lead for complex (5-10), projects which the role will be• Oversee all CSV lifecycle activities expected to perform in• Schedule qualification activities and personnel to meet business, short to medium future.Make sure that you list the manufacturing, engineering and quality objectives accountability on top,• Mentor junior specialists which the role will be doing• Revise and maintain CSV SOPs most frequently and which has most impact on the the• Assess departments standing in the business and regulatory• Function as CSV SME in Inspections and Audits action word, e.g. Providesappropriate coaching and• Perform other duties as assigned.EducationField of Computer Science /Degree (required)* Bachelor’s DegreeStudy Software Engineering Advanced - 5-10 years Validation• Learns from experience, errors and setbacks• Helps others learn from experience to develop themselves• Challenges the status quo and looks for opportunities to makeimprovements in his/her area of the business and beyondAgility• Embraces new initiatives and drives successful implementation in his/her area• Adapts thinking and behavior to support change• Takes personal responsibility for promoting change in his/her area• Understands how to effectively engage others in the change processes• Understands and explains the corporate strategy to his/her peers and/orCollaboration• Generously shares information and knowledge with others across teams and functions• Actively seeks out and shares different perspectives from a broad network and implements alternative approaches• Champions and role models the values of diversity and inclusion through everyday interactions in groups or 1:1s• Proactively seeks to understand internal/external customer and market needs• Develops insights that can be used to enhance customer satisfaction or other metrics• Identifies when company and customer interests may not align and seeksCustomer Focus• Manages internal and external customer relations professionally and effectively• Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement• Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team)• Proactively shares credit for successes• Helps peers (and team) overcome performance obstacles and challenges• Secures buy-in from key stakeholdersResponsibilitiesAdherence to cGMPs is required at all times during the manufacture of drug products. All personnel own the quality of what they deliver andQuality are responsible for notifying responsible management in a timely manner of serious GMP deficiencies, process deviations, product defects and related actions.Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly reportSafety actual and potential accidents and injuries.Must comply with safety policies of the company and site.Skills:• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation• Strong written and oral communication skills• Strong organizational and time management skillsManager's Signature and Date Employee's Signature (optionalWork Schedule* Regular Office HoursMust know and follow job safety procedures, attend required health andsafety training, proactively promote safety at work, and promptly report