BTA (m/w/d)
Core
Conducting particle and microbiological hygiene monitoring in cleanrooms and aseptic production environments, including equipment qualification and GMP documentation.
Role type
Quality Control Technician (Hygiene Monitoring)
Builds
GMP-compliant sterile drug manufacturing environments
Domain
Pharmaceutical manufacturing / Biotechnology / Aseptic production
Required skills
Particle measurement, Microbiological monitoring, Equipment qualification, GMP documentation, ISO 14644 knowledge, EU-GMP Annex 1 knowledge, SAP usage, Growth Direct System operation
Preferred skills
Cleanroom classification expertise, Sterile manufacturing experience
Technologies
SAP, Growth Direct System, Particle counters, Incubators
Responsibilities
Conducting particle measurements in cleanrooms and on pure media, Performing microbiological hygiene monitoring in aseptic and solid-state production, Executing equipment qualification and requalification, Creating GMP-relevant documents, Managing sample storage and analysis in automated systems, Maintaining monitoring equipment
Seniority
Mid-level, hands-on IC