Job DescriptionThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.The state-of-the-art multi-purpose manufacturing facility is designed for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.As a member of the Quality Control management team the position holder manages the Microbiology Unit (MBQC) at Thermo Fisher, Lengnau site according to project timelines and future routine demands.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
Ensure MBQC labs are every time ready for Health Authorities inspection (audit readiness) & Customer visits
Responsible for the timely evaluation, development, validation and re-validation of Microbiological QC test procedures as well as evaluation, procurement, qualification, re-qualification, maintenance (service/cleaning), calibration and monitoring of equipment
Ensure timely and compliant collection of all QC analytical samples and all required materials and reagents, including “reference and control” materials (reagents, test-kits, standards, etc.) are available
Timely execution and evaluation of analytical testing (either internally or externally tested) to ensure business expectations are met
Ensure testing results are documented 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 to QC/QM/LGN projects
Your qualifications:
University Degree (Master or higher) in Microbiology, Biology or Life Science
Many years of experience in highly regulated industry (GxP, Food, Medical Device)
Proven experience as 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 a required
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects an exciting company culture that stands for integrity, intensity, involvement, and innovation!Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today!Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Agency note!Please note that we are not interested in commercial placement offers from personnel service providers. If you decide to send us unsolicited application documents or to upload them, they will not be considered and will be deleted in accordance with our data protection guidelines
