Manager Microbiological Quality Control, Lengnau

Work Schedule

Environmental Conditions

Job Description

Crafted advanced manufacturing facility for large-scale biologics production with high expansion potential.

Lead the Microbiology Unit (MBQC) at Thermo Fisher's Lengnau site as part of the Quality Control management team.

Your responsibilities:

• Ensure the continued update of the operational procedures related to the QC area to align with the latest quality requirements
• Lead, develop and maintain GMP innovative laboratories for Microbiological analytics and ensure procedural documents are in place to accurately lead Microbiological related processes and testing
• Responsible for the sampling team that comprises clean utilities, environmental monitoring, and raw material samples
• Ensure MBQC labs are always ready for Health Authorities inspection (audit readiness) and Customer visits
• Coordinate the timely evaluation, development, validation, and re-validation of Microbiological QC test procedures as well as coordinate the evaluation, procurement, qualification, re-qualification, maintenance (service/cleaning), calibration, and monitoring of equipment
• Collect QC analytical samples and required materials promptly, ensuring availability of all necessary "reference and control" materials.
• Timely execution and evaluation of analytical testing (either internally or externally tested) to ensure business expectations are met
• Ensure testing results are detailed according to GDP and in a way to preserve data integrity
• Consistent and timely investigation of OOE/OOS-results and laboratories deviations
• On demand, support and lead internal QC/QM/LGN projects

Your qualifications:

• University Degree (Master or higher) in Microbiology, Biology, or Life Science
• Many years of experience in a highly regulated industry (GxP, Food, Medical Device)
• Proven experience as a people manager in quality control
• Confirmed experience and knowledge in Microbiological QC methods, method validation, and analytical issue management
• Knowledge in sampling of utilities, environmental monitoring samples, and raw materials
• Able to lead by example, providing technical and personal support
• Excellent time management skills, with the flexibility to handle changing priorities and multiple tasks at the same time
• Working proficiency in English and the ability to communicate in German is required