QC Systems Validation Lead Specialist
United States, Portsmouth (New Hampshire)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 in Portsmouth, NH is searching for a QC Analytical Instrument and Computer Systems Validation Lead, to join our QC team. As a QC Lead, you will complete computer systems validation tasks in accordance with company policies/procedures, customer requirements and regulations. You will manage and perform installation qualification of analytical instruments, operational qualification of application software, configuration of users and file access on computerized systems to ensure systems meet data integrity requirements. Our QC Leads will also be a technical writer of QC documentation including risk assessments, test methods, protocols, reports, SOP’s, and change controls.
- Analytical instrument and computer validation - Write system configuration and administration documents for analytical instrumentation. Perform validation related testing (ex. test scripts, protocols and reports).
- Project management - Manage validation projects from start to finish to meet Laboratory timelines. Represent the department through meeting for both internal and external customers
- Customer support – Participate in resolution of help-desk requests. Administer QC laboratory applications (ex. LIMS, Empower 3)
- Data Integrity - Identify and remediate gaps through implementation of IT/OT engineering controls for analytical instrument and software applications.
- Provide guidance to junior staff or other teams to achieve goals in accordance with established policies.
- Bachelor Degree. Preferred area of study in Computer Science, Microbiology, Biochemistry or Related Science Fields.
- Significant working experience within industry in a quality control lab setting.
- Previous experience using GMP Quality Systems (ex. TrackWise, LIMS, iLab, and Empower 3).
- Excellent communication skills with the ability to collaborate across multiple teams and projects.
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.