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Commissioning and Qualification Specialist

Alvotech · Reykjavik

🇬🇧 English

Job description

About the role

Alvotech is looking for a Commissioning & Qualification (C&Q) Specialist to support the commissioning, qualification and validation of GMP‑critical equipment, utilities and facilities. You will work closely with experienced colleagues, develop technical expertise and help ensure compliance with global regulatory standards in a fast‑paced biopharmaceutical environment.

Key responsibilities

  • Drive and support GMP commissioning and qualification activities 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 cross‑functional teams including QA, Engineering, Automation and Project Management.
  • Stay current with industry standards and regulatory requirements.
  • Take part in training programmes to build competence in qualification and compliance.

Required profile

  • Technical degree (Bachelor’s or equivalent) in Engineering, Life Sciences or a related field.
  • Basic understanding of GMP principles or a strong willingness to learn.
  • Internship or practical experience in a regulated or technical environment is a plus.

Required skills

  • Strong analytical and problem‑solving mindset.
  • Clear and effective communication abilities.
  • Organised, dependable and eager to learn.
  • Ability to manage tasks with guidance and support.
  • Collaborative approach and willingness to work cross‑functionally.

What we offer

  • Opportunity to work on ambitious projects that impact patients' lives.
  • International, diverse and inclusive work culture.
  • Support for personal growth and internal career development.
  • Excellent in‑house canteen, coffee house and wellbeing facilities.
  • Transportation grant for eco‑friendly travel and home‑internet support for full‑time employees.

Questions fréquentes

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Published 1 month ago

Expires 3 weeks from now

22 views · 0 interested

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Alvotech

Reykjavik