Join a dynamic team at a leading Contract Manufacturing Organisation (CMO) and contribute to groundbreaking projects and cutting-edge solutions.
Proclinical is seeking a Bioprocess Engineer DSP to join a dynamic team for a contract role. In this role, you will focus on overseeing and supporting manufacturing campaigns in microbial fermentation while ensuring compliance with cGMP guidelines. This position involves working on production documentation, troubleshooting equipment, and contributing to capital investment projects for manufacturing units. If you are detail-oriented, solution-driven, and thrive in a collaborative environment, this could be the perfect opportunity for you.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
1. Oversee and support the execution of manufacturing campaigns in microbial fermentation.
2. Prepare and execute SHE EM operation and cleaning risk analyses for assigned products, implementing and controlling defined measures.
3. Establish and review production documentation, including electronic batch records, specific to the assigned production area.
4. Perform manufacturing activities according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, and troubleshooting equipment.
5. Review production documentation and address deviations, change requests, and CAPAs to maintain high-quality GMP standards.
6. Act as a production expert in capital investment projects, contributing to the setup, commissioning, and qualification of manufacturing suites and equipment.
7. Prepare, modify, and review DeltaV recipes for equipment and facility components.
8. Coordinate and support engineering and workshop teams for campaign preparation and facility changeovers.
9. Execute innovation and improvement projects related to general manufacturing aspects of the production plant.
10. Train operators on manufacturing processes for assigned products.
11. Represent the production unit during customer audits and visits.
12. Perform other duties as assigned.
Key Skills and Requirements:
13. Degree in Biotechnology, Biochemistry, or a related discipline (Bachelor's, Master's, or PhD).
14. Strong expertise in biotechnology or biotechnical engineering, preferably in microbial fermentation.
15. Excellent understanding of GMP standards.
16. Proficiency in English; German is a plus.
17. Strong communication skills and ability to collaborate across various interfaces within the organization.
18. Structured, focused, and well-organized working style with a solution-oriented mindset.
19. Knowledge of MES and DeltaV systems is highly desirable.
20. On-site presence required; no home office option available.