Posted 6 days ago

Process Engineer – DSM Upstream & Downstream

IS10 Alvotech hf Iceland, Reykjavik Headquarters
Onsite Full Time
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Job description

Are you interested in applying your process engineering expertise to support the manufacturing of life-changing biologic medicines? We are looking for two Process Engineers to join our Drug Substance Manufacturing (DSM) team: one specializing in Upstream Manufacturing and one specializing in Downstream Manufacturing. The Process Engineer is responsible for providing technical support, process optimization, troubleshooting, and lifecycle management of upstream and downstream manufacturing processes to ensure reliable, compliant, and efficient operation of manufacturing systems. Scope and Responsibility Provide day-to-day engineering support for Drug Substance Manufacturing operations, covering both Upstream and Downstream processes. Monitor manufacturing performance and identify opportunities for process optimization, reliability improvements, and capacity enhancements. Support GMP manufacturing activities including cell culture, bioreactor operations, harvest, filtration, chromatography, viral inactivation, ultrafiltration/diafiltration, and bulk drug substance handling. Lead technical investigations related to process deviations, quality events, out-of-trend results, and manufacturing issues. Perform root cause analyses and implement effective corrective and preventive actions (CAPAs). Own and execute process changes through the site change control system. Support process validation, characterization studies, technology transfers, and continuous process verification activities. Develop, review, and improve process-related documentation including SOPs, risk assessments, engineering studies, and technical reports. Collaborate with Manufacturing, MSAT, Quality, Validation, Automation, and Engineering teams to ensure robust process performance. Participate in equipment and process design reviews for new installations, upgrades, and facility expansion projects. Support qualification and commissioning activities related to upstream and downstream equipment. Analyze manufacturing data and trends to drive operational excellence initiatives. Support regulatory inspections, customer audits, and internal audits. Maintain process knowledge and contribute to technical training and knowledge transfer activities across the organization. Promote a culture of safety, compliance, continuous improvement, and operational excellence.

Job Requirements

Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Engineering, or a related scientific discipline.

Experience

working in biopharmaceutical manufacturing, process engineering, MSAT, or technical operations. Knowledge of GMP regulations and pharmaceutical quality systems.

Experience

with deviation investigations, change controls, CAPAs, risk assessments, and process validation activities.

Experience

with process monitoring, statistical analysis, and continuous improvement methodologies. Ability to work effectively in cross-functional teams within a fast-paced manufacturing environment. Excellent verbal and written communication skills in English.

Preferred Qualifications

Experience

in commercial biologics manufacturing. Knowledge of single-use technologies and large-scale bioprocessing equipment. Familiarity with DeltaV, PI Historian, MES, SAP, or similar manufacturing systems.

Experience

supporting regulatory inspections and audits.

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. Excellent in-house canteen and coffee house. Exercise and wellbeing support for full-time employees. On-site shower facility. 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. At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high-quality, affordable biologic medicines for patients worldwide. Our people are central to that mission. Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged. Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business. Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale. If you do not see a role that matches your experience today, we still welcome general applications from individuals who share our ambition and want to help improve access to biologic medicines worldwide. If you have any technical issues, please contact: hr@alvotech.com

Skills and functions

  • Customer Support