Microbiologist (GMP) Sterile Areas | Mikrobiologe (GMP) Sterilbereich (A–D) – Annex 1, CCS, EM | Dresden (m/w/d)
ROTOP Pharmaka GmbH
Job Summary
This role offers a pivotal opportunity to join ROTOP Pharmaka, a leading international pharmaceutical manufacturer in Dresden. As a Microbiologist specializing in sterile environments (Grades A–D), you will hold technical responsibility for ensuring compliance with EU-GMP Annex 1 standards. Your day-to-day activities will involve developing and maintaining the Contamination Control Strategy (CCS), managing Environmental Monitoring (EM) programs, and overseeing microbiological testing such as bioburden, sterility, and endotoxin assays. You will be a key collaborator across production, quality control, and engineering departments to manage deviations, root-cause analyses (CAPA), and aseptic process simulations. This position is particularly attractive due to its focus on cutting-edge radiopharmaceuticals, a modern green-campus work environment, and a commitment to work-life balance with no shift work and flexible hours. It is an ideal career step for a quality-oriented professional looking to influence hygiene concepts and contamination prevention in a growing, future-proof industry.
Required Skills
Education
Master's degree (MSc) or PhD in Microbiology, Biology, Biotechnology, Pharmacy, or a comparable field of study.
Experience
- Several years of professional experience in GMP-regulated microbiology
- Practical experience in sterile production environments (Grades A–D)
- Proven experience in method and process validation
- Experience in deviation management and CAPA processes
- Experience in preparing for and participating in regulatory audits and inspections
Languages
Additional
- The role is based in Dresden (01328). It is a full-time, permanent position with no shift work required.
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