Microbiologist (GMP) Sterile Areas – Annex 1, CCS, EM | Mikrobiologe (GMP) Sterilbereich (A–D) – Annex 1, CCS, EM (m/w/d)
ROTOP Pharmaka GmbH
Job Summary
As a Microbiologist in the sterile production sector (Grades A–D), you will hold technical responsibility for microbiological processes compliant with EU-GMP Annex 1. Your day-to-day work involves establishing and advancing the Contamination Control Strategy (CCS) in close collaboration with Production, Quality Control, Quality Assurance, and Engineering. You will lead the planning and trend analysis of Environmental Monitoring (EM) for air, surfaces, and personnel, ensuring data integrity and robust reporting. Additionally, you will oversee microbiological testing such as bioburden, sterility, and endotoxin tests. A significant part of the role includes managing deviations, Out-of-Specification (OOS) results, and Root-Cause-Analyses to define effective CAPAs. This position is particularly attractive due to its permanent contract, modern work environment in Dresden, and a commitment to work-life balance with flexible hours and no shift work, all within a growing international pharmaceutical company.
Required Skills
Education
Completed university degree (MSc or PhD) in Microbiology, Biology, Biotechnology, Pharmacy, or a comparable field.
Experience
- Several years of professional experience in GMP-regulated microbiology
- Practical experience in sterile production environments
- Proven experience in method/process validation and deviation management
- Experience in preparing and supporting regulatory audits and inspections
- Experience in conducting technical training on aseptic behavior and hygiene concepts
Languages
Additional
- The role is based in Dresden (01328), Germany. It is a full-time, permanent position requiring a highly structured and quality-oriented way of working.
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