Senior Commissioning and Qualification Specialist

Are you an experienced GMP professional with a passion for commissioning and qualification? Do you thrive in high‑impact projects that support cutting edge biopharmaceutical production? We are looking for a Specialist in Commissioning & Qualification (C&Q) to join our team and ensure that our facilities, systems, and equipment operate to the highest global standards.

In this role, you will be responsible for the commissioning and qualification of GMP-critical systems, ensuring full compliance with EU and US regulatory expectations for parenteral biopharmaceutical manufacturing. You will lead and contribute to strategic projects, mentor colleagues, and collaborate across departments to drive quality and innovation. 

Key Responsibilities 

• Lead 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. 

• Stay current with industry standards and regulatory requirements. 

• Provide training and guidance to relevant staff on qualification compliance.
   

Qualifications: 

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

• Strong understanding of GMP regulations, qualification documentation, and discrepancy/deviation handling.
   

Skills: 

• Strong analytical and problem-solving skills. 

• Excellent communication and people skills. 

• Ability to manage multiple priorities in a fast-paced environment.

• Proactive, organized, and confident in driving tasks forward

• Demonstrated success in cross-functional collaboration.
   

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.