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Portsmouth, New Hampshire, United States
Onsite
Computer Systems Validation (Analytical) Supervisor
Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.
As the Computer Computer Systems Validation (CSV) Supervisor you will lead a team of professionals to deliver validation projects on schedule while ensuring strict adherence to Quality and Data Integrity standards. You will collaborate with Operations Technology (OT), Engineering, and Quality Assurance to support site goals, enhance compliance, and drive on-time, right-first-time performance.
What you will get:
Competitive salary and comprehensive benefits package.
Opportunities for career development and advancement.
Supportive and collaborative team environment.
Access to cutting-edge technology and tools.
Commitment to employee well-being and safety.
Inclusive workplace culture.
Recognition and reward for your contributions.
Access to our full list of global benefits: https://www.lonza.com/careers/benefits
What you will do:
Provide technical support for the design, operation, and troubleshooting of analytical equipment across departments.
Lead the planning and execution of equipment-related IQ/OQ/PQ validation plans and process improvements.
Manage Quality Management System (TW) records, review EDMS documents, and lead risk assessments and change controls.
Identify quality concerns, engage stakeholders, and drive issues to final resolution.
Coach and develop staff through performance reviews, career planning, and consistent 1:1 meetings.
Handle administrative duties, including daily meetings, task assignment, and hiring/onboarding activities.
Partner with CSV, OT, and other validation teams to ensure site-wide consistency and compliance.
What we are looking for:
Bachelor’s degree of Science/Engineering is required.
5-10 years’ of Computer Systems Validation experience – Manufacturing and QC systems.
Advanced knowledge of manufacturing operations, Validation principles (process, equipment, systems), and Data Integrity.
Hands-on experience managing deviations, change controls, and CAPAs within systems like TrackWise.
Proven ability to lead medium-to-large projects, drive planning/controlling, and utilize tools like RCA, FMEA, and VSM.
Strong verbal/written communication skills and effective leadership in fostering cross-functional, customer-focused collaboration.
Expert knowledge of GMP/Safety standards and proficiency in MS Office (Project, Excel, Word, PowerPoint).
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
