Computer Systems Validation Specialist Level 3

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 Computer System Validation Specialist Level 3 to join their team in Portsmouth, NH.

POSITION:                 Computer System Validation Specialist Level 3

JOB LOCATION:      101 International Drive, Portsmouth, NH 03801 [and various unanticipated locations throughout the U.S.; may work from home]

Computer System Validation Specialist Level 3 needed by Lonza Biologics Inc.in Portsmouth, NH [and various unanticipated locations throughout the U.S.; may work from home] to support team members to assess new and changing computer systems to ensure compliance with company policies, procedures, and industry guidance. 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 (Change Control, Deviations, and CAPAs) creation and execution process. Provide Subject Matter Expert (SME) support as a Computer System Validation (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 of computerized systems. Review and revise CSV Standard Operating Procedures (SOPs). Perform review of Engineering documents including 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. Support computerized system validation lifecycle. 

MINIMUM REQUIREMENTS: Requires a Bachelor degree, or foreign equivalent degree, in Computer Science, Software Engineering, or Computer Engineering and 2 years in the job offered or 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 drafting protocols as required to implement changes to computerized systems; supporting Quality record (Change Control, Deviations, and CAPAs) creation and execution process; and performing Validation Maintenance and periodic reviewing 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.