Microbiologist (GMP) Sterile Area (A–D) – Annex 1, CCS, EM (m/f/d) | Dresden

Permanent employee, full- or part-time, Dresden, Dresden

Your chance with us

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.

More than just a job

Permanent position in a future-proof and internationally active company
No shift work for the best work-life balance
30 days of vacation
10 paid days off when your child is sick
Modern workplace surrounded by greenery (Dresden 01328)
Canteen subsidy, company parking, and e-charging facilities
3 days of goodwill / K.O. days
Job bike and job ticket for sustainable mobility
Team-building company events for a strong sense of unity
Accident insurance, including for private use
Diverse career and development opportunities and other 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.