Quality Control Biotesting Expert | Experte QC Biotesting (m/w/d)
Roche Diagnostics GmbH
Job Summary
As a Quality Control Biotesting Expert at Roche in Mannheim, you will join the Sterile Drug Product Manufacturing (SDPM) division to ensure the safety and efficacy of life-changing medications. Your primary focus will be on endotoxin analysis, examining raw materials, packaging, water, and final parenteral products. Day-to-day, you will plan and execute timely analytics, manage equipment qualifications, and oversee method validations within a strict GMP environment. You will act as a key coordinator between local and global units, driving innovation in automation and new technologies. This role is ideal for those who enjoy root cause analysis, deviation management, and working in a highly regulated, collaborative setting. Roche offers a unique opportunity to contribute to a vision of delivering 20 breakthrough medicines by 2029, fostering a culture where personal expression and professional growth are deeply valued.
Required Skills
Education
Bachelor's or Master's degree in Biology (focus on Microbiology), Biotechnology, or a related field; or a Technician qualification with several years of relevant professional experience.
Experience
- Professional experience in a microbiology laboratory within the pharmaceutical industry
- Extensive experience in endotoxin analysis and parenteral drug manufacturing steps
- Proven experience in handling deviations and change control processes
- Experience working in global, interdisciplinary teams and managing cross-site interfaces
- Experience with laboratory IT systems including LIMS and SAP
Languages
Additional
- Willingness to work in a flexible model including weekend shifts; primary work location is on-site in Mannheim, Germany.
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