Bioprocess Engineer/DSP (m/f/d)

Key Accountabilities and Duties

• Oversees, plans and supports execution of manufacturing campaigns in the area of microbial fermentation
• Responsible to prepare and execute SHE, EM, operation and cleaning risk analysis for the assigned products and the implementation and control of defined measures.
• Responsible to establish timely and with high quality the required production documentation (preparation and review of electronic batch records) specific to the assigned production area.
• Perform manufacturing activities according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution.
• Reviews production documentation and works on deviations, change requests and implementation of CAPAs to ensure high-quality GMP standards.
• Working as production expert in Capital investment projects for building and commissioning of the manufacturing units. Responsible for delivering all input required for the specific set-up, commissioning and qualification of the manufacturing suites and equipment including automation.
• Prepares, changes and reviews DeltaV recipes for equipment and facility parts.
• Coordinates and supports Engineering and workshops for campaign preparation and change-over activities in the facility.
• Executes innovation and improvement projects comprising general manufacturing aspects for the production plant.
• Responsible for training of the operators for the manufacturing of the assigned products.
• Represents own area / unit during customer audits and visits

Required Qualifications and Skills required:

• Bachelor / Master Degree / PhD - Preferred area of study: Biotechnology, Biochemistry or related disciplines
• 3-5 years of relevant experience
• Good biotechnology expertise and knowledge in biotechnical engineering preferable in the area of microbial fermentation
• Excellent GMP understanding
• Good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation