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.
Lonza is currently seeking a CSV Specialist Level 3 to join their team in Portsmouth, NH.
POSITION: CSV Specialist Level 3
JOB LOCATION: 101 International Drive, Portsmouth, NH 03801 [and various unanticipated locations throughout the U.S.; may work from home]
DUTIES: Support team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. Support computerized system validation lifecycle. Adopt a risk-based approach to validate computer systems. Review and assess change requests and draft protocols as required to implement changes to computerized systems. Support quality record including Change Control, Deviations, and CAPAs for creation and execution process. Provide SME support, as a CSV representative during small and large-scale projects. Execute all responsibilities as a project lead for CSV projects. Guide and perform all CSV qualification activities. Perform Validation Maintenance and periodic review of computerized systems through their operational lifecycle. Review and revise CSV SOPs. Perform review of Engineering documents P&IDs, SOPs, and Specifications. Identify gaps and support creation and implementation of solutions/gap remediation plans. Assist with audits and inspections. Perform other duties as assigned by the management to support continuous process improvements.
MINIMUM REQUIREMENTS: Requires a Bachelor’s degree or foreign equivalent degree, in Computer Science, Software Engineering, or Engineering and Two (2) Years of experience in the job offered, or Two (2) Years of experience in a related occupation supporting computerized system validation lifecycle; adopting a risk based approach to validate computer systems; reviewing and assessing change requests and draft protocols as required to implement changes to computerized systems; supporting quality record including Change Control, Deviations, and CAPAs for creation and execution process; and performing Validation Maintenance and periodic review of computerized systems through their operational lifecycle.
Every 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.
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What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
