Principal Specialist - QA Engineering

Key responsibilities and minimum requirements according to the role:

• Provide QA oversight and collaborate with cross-functional teams in planning maintenance, qualification, and validation activities for facilities, utilities, equipment, and computer systems (CSV).
• Serve as a Quality representative and a subject matter expert (SME) in selection, design and build of new technologies and new facilities within Alvotech.
• Support and provide QA oversight with review and approval of qualification documents for facility, utility, equipment and computerized systems as applicable.
• Contribute to investigations into discrepancies arising during qualification / validation activities and subsequent approval of appropriate corrective actions.
• Review of planned and unplanned work orders for maintenance, preventive maintenance, calibrations and other Engineering related activities.
• Reviews and approve change controls, deviations , CAPAs , effectiveness checks for facilities, utilities, and equipment, computer systems.
• Stay current on applicable external requirements and industry standards and drive continuous improvement on Engineering and CSV processes and tools.
• Advice on quality matters, and assistance for closing compliance gaps found in audits and inspections.
• Escalation of any data integrity or critical quality issues to the supervisor and Quality Management of Alvotech
• Responsible for ensuring all facilities, utilities, equipment , computer systems are appropriately validated and qualification in line with current EU and US legislation for parenteral/biologics. Minimum education and experience required for the role:
• A bachelor’s degree within relevant area, or other relevant business experience
• Minimum 5 years of experience within the Pharmaceutical or Medical Device Industry (preferably in parenteral/biologics formulations).
• Experience working with regulatory requirements in GxP required (Preferably FDA and EU regulations).
• Good understanding of GAMP 5 guide required.
• Knowledge of and experience with validation and qualification specifically within facility, utility, and equipment/computer systems. At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business. Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale. If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide. If you have any technical issues, please contact: hr@alvotech.com