Technician, Quality Control - Environmental Monitoring (m/w/d)
Core
Perform environmental monitoring (EM) in classified biopharmaceutical production and filling areas, including sampling and analysis of utility systems.
Role type
Technician, Quality Control - Environmental Monitoring
Builds
Supports Parenteral Operations and QC Microbiology labs in a new high-tech manufacturing facility.
Domain
Biopharmaceuticals / Manufacturing / Quality Control
Deliverable
physical/clinical work
Required skills
Environmental monitoring techniques, Sampling and analysis, Incubation, Data integrity, cGMP compliance, Laboratory IT systems (LIMS, LES, MODA), Aseptic production support, Utility system monitoring (air, water, steam), Documentation
Preferred skills
Microbiology background, Aseptic manufacturing experience, Root cause analysis, Training and mentoring, Cleanroom gowning
Technologies
LIMS, LES, MODA
Responsibilities
Conduct routine and investigative environmental monitoring in cleanrooms and RABS, Support QC Microbiology labs with sample incubation and verification, Ensure data integrity and cGMP compliance, Participate in qualification activities and continuous improvement projects, Support regulatory inspections
Seniority
Entry to Mid-level, Hands-on Technician
