The Role
Provides technical and engineering support for upstream and downstream drug substance manufacturing. Responsibilities include process optimization, troubleshooting, deviation investigations, root cause analysis, CAPAs, change controls, validation, technology transfers, documentation, data analysis, equipment qualification, audits, and cross-functional collaboration across GMP biologics operations.
Summary Generated by Built In
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 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.
Skills Required
- Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Pharmaceutical Engineering, or a related scientific discipline
- Experience 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
- 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
- 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
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The Company
What We Do
Alvotech is a global biotechnology company focused exclusively on developing and manufacturing biosimilar medicines. Its mission is to improve patients’ lives by expanding access to affordable biologic treatments worldwide. The company operates as a fully integrated specialty biopharmaceutical business, pursuing high-quality biosimilars and building treatment options that can make important biologic therapies more accessible to patients through its research, development, and production capabilities.
