Would you like to become part of an international company in a future-proof industry? Due to our continuous growth, we are offering a permanent position in a modern working environment surrounded by greenery in Dresden (01328). As a microbiologist (m/f/d), you can expect challenging tasks, flexible working time models, and attractive benefits for an optimal work-life balance.
Microbiologist (GMP) Sterile Area (A–D) – Annex 1, CCS, EM (m/f/d) | Dresden
Dresden
Full or part-time
Permanent employee
Your chance with us
More than just a job
- A permanent position at a future-proof, internationally active company
- No shift work and flexible work schedules to help you balance family and career
- 30 days of vacation to recharge
- 10 paid sick days for children to support your family
- A modern workplace (e.g., height-adjustable desks) surrounded by greenery
- Company parking and electric vehicle charging stations
- 3 days off for personal reasons
- Access to a wide range of attractive benefits via our ROTOP Benefits Portal
- Job-Rad and Jobticket for sustainable mobility
- Team-building company events to foster a strong sense of community
- Diverse career and development opportunities and additional benefits
Your tasks
- Technical responsibility for Annex 1-compliant microbiological processes in sterile areas (A–D), including the establishment/further development of the Contamination Control Strategy (CCS) in close cooperation with Production, QC, QA, and Engineering
- Planning, evaluation, and trend analysis of environmental monitoring (EM) (air, surfaces, personnel), including limit value system, data integrity, and reporting
- Supervision and optimization of microbiological tests (bioburden, sterility, and endotoxin tests), including germ/isolate identification
- Processing of deviations and OOS/OOT, including root cause analysis, CAPA definition, and effectiveness testing with a focus on microbiological processes
- Creation and maintenance of microbiological risk analyses/assessments and support for change controls
- Collaboration on validations (e.g., aseptic process simulations/APS, disinfectant validation, cleaning concepts) and creation/maintenance of SOPs, test plans, reports, and training documents
- Preparation and support of audits/inspections (authorities, customers) with a focus on Annex 1, as well as conducting technical training/coaching on aseptic behavior, contamination prevention, and hygiene concepts
Your profile
- Completed degree (MSc/PhD) in microbiology, biology, biotechnology, pharmacy, or comparable field
- Several years of experience in GMP-regulated microbiology, ideally in sterile production
- Very good understanding of the requirements of EU GMP Annex 1 (e.g., CCS, environmental monitoring, asepsis, disinfection, trend analysis)
- Practical experience in method/process validation, deviation management, and CAPA
- Confident handling of data integrity (ALCOA+)
- Structured, quality-oriented approach to work, strong communication skills, team spirit
- Very good German skills, English skills an advantage
Your team
Become part of a growing team and help shape the future with us! Apply now as a microbiologist (m/f/d) and seize the opportunity to advance your career in a modern and international environment.
If you would like to contribute your skills in an innovative environment and develop personally, we look forward to receiving your application. Send it by email to bewerbung@rotop-pharmaka.de, attn. Sven Schäfer, or apply directly online.
About us
We are ROTOP Pharmaka GmbH, a leading pharmaceutical manufacturer in Germany, headquartered in Dresden-Rossendorf. For more than 25 years, we have developed, manufactured, and supplied cGMP-compliant radiopharmaceuticals for diagnostics and therapy in nuclear medicine and molecular imaging – distributed to more than 40 countries worldwide.
The ROTOP brand stands for quality, reliability, and pharmaceutical expertise. As a radiopharmaceutical manufacturer, we focus on close customer relationships, collaborative partnerships, and tailored radiopharmaceutical solutions for hospitals, clinics, and research partners. Our mission: advancing the medicine of tomorrow – developed and manufactured with responsibility.
ROTOP Pharmaka stands for integrity, expertise, and commitment – from Dresden to the future of nuclear medicine.
The ROTOP brand stands for quality, reliability, and pharmaceutical expertise. As a radiopharmaceutical manufacturer, we focus on close customer relationships, collaborative partnerships, and tailored radiopharmaceutical solutions for hospitals, clinics, and research partners. Our mission: advancing the medicine of tomorrow – developed and manufactured with responsibility.
ROTOP Pharmaka stands for integrity, expertise, and commitment – from Dresden to the future of nuclear medicine.