Commissioning and Qualification Specialist

Langar þig að byggja upp feril í stjórnun, prófun og staðfestingu á GMP‑búnaði og kerfum? Hefur þú áhuga á hagnýtri tækni­vinnu sem skiptir raunverulegu máli í framleiðslu á líftæknilyfjum? Við hjá Alvotech leitum að Specialist í Commissioning & Qualification (C&Q) til að styrkja teymið okkar og tryggja að búnaður, kerfi og aðstaða uppfylli alþjóðlega GMP‑staðla.

[English]

Are you motivated to grow your career in the management, commissioning, and qualification of GMP pharmaceutical equipment and systems? Do you enjoy hands‑on technical work that contributes directly to high‑quality biopharmaceutical production? We are seeking a Specialist in Commissioning & Qualification (C&Q) to support our team in ensuring that our facilities, systems, and equipment meet global regulatory standards.

In this role, you will assist with commissioning and qualification activities for GMP‑critical systems, collaborating closely with experienced colleagues while developing your skills and technical expertise. You will collaborate across departments, learn industry best practices, and help maintain compliance within a fast‑paced and innovative environment.

Key Responsibilities

• Drive and support GMP commissioning and qualification activities for facilities, utilities, and equipment (manufacturing and laboratory).

• Generate, execute, review, and approve qualification documentation (e.g., URS, IQ/OQ/PQ protocols, validation plans, summary reports).

• Participate in change control, deviations, and CAPA processes.

• Collaborate with cross-functional teams including QA, Engineering, Automation, and Project Management.

• Learn and stay current with industry standards and regulatory requirements.

• Participate in training and develop competence in qualification and compliance processes.

Qualifications:

• Technical degree (Bachelor’s or similar) in Engineering, Life Sciences, or another relevant technical 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.

Skills:

• Strong analytical and problem-solving mindset.

• Clear and effective communication skills.

• Organised, dependable, and eager to learn.

• Ability to manage tasks with support and guidance.

• Collaborative approach and willingness to work cross‑functionally.

What we offer:

• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.

• The chance to be a part of a global and fast-growing company.

• An international work culture that encourages diversity, collaboration and inclusion.

• Positive, flexible, and innovative work environment.

• Support for personal growth and internal career development.

• Company social events and milestone celebrations.

• Excellent in-house canteen and coffee house.

• Exercise and wellbeing support for full-time employees.

• On-site shower facility.

• Transportation grant towards eco-friendly modes of travel for full-time employees.

• Internet at home for full-time employees.
  

Why Alvotech

At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.