Computer Systems Validation Supervisor
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Responsibilities
- 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.
Requirements
- 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
- Ready to shape the future of life sciences?
Additional Information
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
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