Computer Systems Validation Specialist, Level 3

United States, Portsmouth (New Hampshire)Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.Job SummaryThe Computer Systems Validation (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 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 and will be involved as the QA CSV representative during small and large-scale projectsWhat You Will GetA collaborative and inclusive work environmentOpportunities for career growth and developmentAccess to cutting-edge technologies and toolsCompetitive compensation and benefits packageSupportive leadership and mentoringCommitment to ethical and sustainable practicesRelocation support if requiredWhat You Will Do Perform all aspects of QMS process’ – Change Control, Deviations, CAPAs Execute all responsibilities as CSV project lead for simple projects Oversee/perform all CSV qualification activities for DeltaV and Syncade systems Perform Validation Maintenance of computerized systems Review/Revise CSV SOPs Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.) Assist with audits and inspections What We Are Looking ForBachelor’s degree in computer science, engineering, or related fieldAt least 2 years of experience in automation or system validation1+ years with Programmable Logic Controllers (PLC), Controls Automation, Process Control Systems, SCADA Systems, Distributed Controls Systems (DCS), Building Alarm Systems (BAS), Building Management Systems (BMS), Manufacturing Execution Systems (MES) required, DeltaV is preferredExperience leading projects and managing CAPAs and deviationsBackground in biotech, pharma, or medical device industryStrong attention to detail and ability to meet deadlinesAbility to work independently and on-site in Portsmouth NHEvery day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.Reference: R71059Apply