Process-Lifecycle Engineer

We are seeking a highly skilled Process-Lifecycle Engineer to join our Commissioning & Qualification (C&Q) department. In this role, you will take ownership of lifecycle management activities across a wide range of GMP‑critical systems, ensuring their continued compliance, performance, and readiness to support high‑quality biopharmaceutical manufacturing.

This role requires strong technical competence, independence, and the ability to make informed decisions in complex, multi‑disciplinary areas. You will contribute to strategic and developmental initiatives, lead critical lifecycle processes, provide expert guidance to colleagues, and collaborate across departments to support operational excellence and regulatory compliance.

Key Responsibilities 

• Lead lifecycle management activities for site systems from a C&Q perspective.

• Coordinate and manage system receival, relocation, decommissioning, and related procedural activities.

• Ensure facilities, utilities, and equipment remain appropriately qualified per EU and US regulatory expectations for parenteral biopharmaceuticals.

• Coordinate and track routine C&Q activities to ensure timely closure.

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

• Work closely with Engineering, QA, Automation, Project Management, equipment owners, process owners, and SMEs in system qualification and lifecycle activities.

• Actively engage in cross‑departmental tasks and initiatives to support company goals.

• 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.

• Solid knowledge of GMP processes, including documentation management, qualification activities, user requirement specifications, and IQ/OQ/PQ execution.

• Experience working with GMP documentation and handling investigations or discrepancies.

Skills: 

• Strong analytical and problem-solving skills. 

• Excellent communication skills. 

• Ability to manage multiple concurrent tasks in a dynamic environment.

• Ability to train and support colleagues on qualification and lifecycle processes.

• 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.