Bioprocess Engineer

Scope of role:

You will be responsible for handling production campaigns in the BioConjugates IBEX facilities for the production of bioconjugates. You will carry out risk analyses, contribute the necessary expertise and ensure compliance with GMP, safety and cleaning regulations. Representing production in direct contact with customers is part of your duties as a member of an interdisciplinary team. You will be involved in project teams such as investments, optimization of processes, activities and systems.

Your tasks:

• You are responsible for the timely, quality and cost-optimized production of the assigned products in compliance with the relevant laws, regulations and guidelines regarding safety, quality, regulation, hygiene and the environment.
• Execution of the operational batch record review (manufacturing records, cleaning records in MES / DeltaV) in accordance with the internal work instructions.
• Correct preparation and execution or review of the risk analysis in the projects assigned to you and the implementation of the resulting measures.
• Conducting production campaigns according to cGMP guidelines, ensuring batch execution, evaluating test results, troubleshooting problems, troubleshooting manufacturing equipment and proposing solutions.
• Documentation of processes and process know-how as well as for the preparation of campaign reports and participation in annual product reviews
• Improve processes, equipment and procedures in cooperation with various project teams from Process Development, MSAT in order to operate processes and equipment efficiently and economically
• Implementation of the relevant GMP documents for the respective area.
• Training of employees for the assigned products (campaign training)