Work Schedule

Other

Environmental Conditions

Office

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 requirementsLead, develop and maintain GMP innovative laboratories for Microbiological analytics and ensure procedural documents are in place to accurately lead Microbiological related processes and testingResponsible for the sampling team that comprises clean utilities, environmental monitoring, and raw material samplesEnsure MBQC labs are always ready for Health Authorities inspection (audit readiness) and Customer visitsCoordinate 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 equipmentCollect 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 metEnsure testing results are detailed according to GDP and in a way to preserve data integrityConsistent and timely investigation of OOE/OOS-results and laboratories deviationsOn demand, support and lead internal QC/QM/LGN projects

Your qualifications:

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