Senior Commissioning and Qualification Specialist

About the role

Alvotech is seeking an experienced GMP professional to lead commissioning and qualification activities for its biopharmaceutical manufacturing facilities. You will ensure that all systems, utilities and equipment meet the highest EU and US regulatory standards while supporting high‑impact projects that bring innovative therapies to patients.

Key responsibilities

• Lead GMP commissioning and qualification for manufacturing and laboratory facilities, utilities and equipment.
• Generate, execute, review and approve qualification documentation such as URS, IQ/OQ/PQ protocols, validation plans and summary reports.
• Participate in change control, deviation handling and CAPA processes.
• Collaborate with QA, Engineering, Automation and Project Management teams to drive quality and innovation.
• Stay up‑to‑date with industry standards and regulatory requirements.
• Provide training and guidance on qualification compliance to relevant staff.

Required profile

• Technical degree (Bachelor’s or higher) in Engineering, Life Sciences or a related field.
• Strong understanding of GMP regulations and qualification documentation.
• Proven experience in GMP commissioning, qualification and discrepancy/deviation handling.
• Excellent analytical, problem‑solving and communication skills.
• Ability to manage multiple priorities in a fast‑paced environment.

Required skills

• GMP regulatory knowledge
• Qualification documentation (URS, IQ, OQ, PQ protocols, validation plans)
• Change control processes
• CAPA (Corrective and Preventive Action) procedures

What we offer

• Opportunity to work on ambitious projects that improve patients' lives.
• International, inclusive work culture with diversity and collaboration.
• Support for personal growth and internal career development.
• Excellent in‑house canteen, coffee house, exercise and wellbeing facilities.
• Transportation grant for eco‑friendly travel, home internet support and on‑site shower facilities.