Process Engineer - Fill Finish - Consulting Assignment 6 months - AstraZeneca
Do you enjoy working in a high-tech production environment with a focus on responsibility, efficiency, and close teamwork? Do you thrive on solving problems within operations while driving long-term improvements and product launches? Then the role of Process Engineer at Sweden Biomanufacturing Center (SBC) could be right for you.
SBC is a central part of AstraZeneca's strategy for manufacturing biological medicines and our primary launch site for biological products. Here we produce and deliver clinical and commercial biological medicines to patients globally – in an operation where we continuously improve methods and processes to meet future demands.
At SBC, you'll become part of a multicultural and global environment where digital solutions, productivity, and sustainability drive us forward – and where you'll have the opportunity to develop.
Your Game Plan
You will work with our established factory with commercial production in Gärtuna. The role is operations-focused and primarily emphasizes stabilizing and improving existing processes, as well as launching new products on existing lines. You will mainly support operations related to filling/fill-finish, in close collaboration with production, quality, and technical functions.
Your Role
As a Process Engineer, you contribute process technical expertise and drive initiatives from analysis to implemented and sustainable solutions.
Process Support to Production: monitor process performance (yield, quality, downtime/disruptions) and drive actions that strengthen robust operations.
Deviation Investigations and Change Management: lead and/or contribute to root cause analyses, risk assessments, CAPA, and implementation of improvements related to process and equipment.
Product Launch and Validation/Qualification: plan, coordinate, and execute activities and review/approve protocols and reports (e.g., IQ/OQ/PQ and process-related validation).
Regulatory Compliance and Inspections: participate as a process technical expert in regulatory inspections/audits and ensure that methods and documentation meet cGMP requirements.
Digitalization and Standardization: contribute to development of methods, standards, and digital tools that simplify and enhance daily operations.
We Expect You to Have/Be
Education: technical/scientific university degree, for example in chemistry, biology, biotechnology, process engineering, or mechanical engineering.
Experience: work in a regulated industry, preferably pharmaceutical manufacturing, with understanding of the interaction between product requirements, materials, process, and equipment.
cGMP: good understanding of cGMP and quality requirements in production.
Validation/Qualification: experience in driving or leading qualification/validation activities and working methodically with documentation.
Languages: good knowledge of Swedish and English, both spoken and written.
Meriting Factors
Experience from aseptic filling and/or sterile manufacturing.
Success Factors
You are comfortable being close to production, take ownership of issues affecting quality and delivery, and can combine precision in GMP work with a pragmatic improvement focus. You collaborate well, communicate clearly, and drive work forward even when the pace is high and conditions change.
About Tessero
Tessero is a specialist company in competence supply and recruitment. In this role, you will be employed as a consultant through Tessero and work on assignment with AstraZeneca in Södertälje.