Validation Engineer 2

Validation Engineer 2Location: Portsmouth, NH Job Duration: 6 monthsThe CSV Specialist Level 3 helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist Level 3 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members. Specialist will be involved as the QA CSV representative during small and large-scale projectsJob DescriptionPerform all aspects of QMS process' – Change Control, Deviations, CAPAsExecute all responsibilities as CSV project lead for simple projectsOversee/perform all CSV qualification activities for DeltaV and Syncade systemsPerform Validation Maintenance of computerized systemsReview/Revise CSV SOPsPerform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.)Assist with audits and inspectionsPerform other duties as assignedCompetencies & BehaviorsDemonstrates an ability and desire to learn from experienceTreats errors as a learning opportunityIs willing to take on new challengesTakes steps to adapt thinking and behavior to support changeSupports a culture of process improvement and problem solvingDemonstrates an openness to trying new approachesSeeks to understand the corporate strategy and how his/her business area contributes to the company's successUnderstands the impact of his/her own actions on his/her business areaExpresses ideas that will improve his/her business areaUses knowledge of his/her business area to make accurate and timely decisionsWorks as an active member of his/her teamGenerously shares information and knowledge with others on teamDemonstrates an openness to different perspectives by balancing listening and speakingTreats all co-workers and customers professionally and with respectUnderstands what internal and/or external customers need from him/her to deliver in his/her respective roleDemonstrates an openness to receiving customer feedbackTakes action to enhance customer satisfaction within the scope of his/her roleConsistently delivers goals while monitoring KPIs with supervisorDemonstrates persistence and motivation to overcome obstacles and challengesEnsures quality standards are maintained while delivering resultsPlans, prioritizes and organizes work to deliver on timeTakes responsibility for his/her safety and that of othersTakes responsibility for personal choices and behaviorsSeeks feedback and reflects on his/her development needs in order to continuously improveContributes to a positive work environmentActs as a reliable and dependable member of the teamSkillsExperience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems ValidationStrong written and oral communication skillsStrong organizational and time management skills