Ready to step into a pivotal role at a global CMO and help shape the future of healthcare manufacturing?
Proclinical is seeking a dedicated and experienced engineer to support manufacturing operations in a biopharmaceutical environment. This role focuses on downstream processing, ensuring compliance with cGMP guidelines, and contributing to the preparation and execution of production campaigns. You will play a key role in troubleshooting, documentation, and process improvement while collaborating across teams to maintain high-quality standards.
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 downstream processing.
2. Prepare and execute risk analyses for safety, health, and environmental operations, implementing and monitoring defined measures.
3. Develop, review, and manage production documentation, including electronic batch records.
4. Perform manufacturing activities in compliance with cGMP guidelines, troubleshoot equipment, and resolve issues.
5. Review production documentation, address deviations, manage change requests, and implement CAPAs to uphold 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 MES-DeltaV recipes for equipment and facility components.
8. Coordinate with engineering teams and workshops for campaign preparation and facility changeovers.
9. Lead innovation and improvement projects related to manufacturing processes.
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. Academic background in Biotechnology, Biochemistry, or related disciplines (Bachelor's, Master's, or PhD).
14. Strong knowledge of biotechnology and/or biotechnical engineering, particularly in downstream processing.
15. Solid understanding of cGMP guidelines and practices.
16. Proficiency in English; German language skills are a plus.
17. Familiarity with MES and DeltaV systems is highly desirable.
18. Excellent communication skills and ability to collaborate across teams.
19. Structured, organized, and solution-oriented working style with a proactive mindset.
20. On-site presence required; remote work is not available for this role.