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Lengnau, Switzerland, Switzerland
Onsite
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information:
This position is part of the Microbiological Quality Control (MBQC) team from Thermo Fisher Scientific in Lengnau (CH), supporting GMP-regulated manufacturing operations. The role operates within a laboratory environment focused on ensuring microbiological quality and compliance of pharmaceutical products and processes.
A Day in the Life:
Coordinate and work on the transfer, development and validation of analytical methods including qualification of equipment needed for analysis.
Actively contribute to the GMP Inspection Readiness of QC to ensure the fully compliance of relevant Quality System and Procedural documents.
Actively contribute to the QC operational readiness managing projects (external and internal) and the assigned to ressources (including coordination of people daily tasks). Participates in the transfer, development and validation of analytical methods including qualification of equipment needed for analysis.
Responsible for development, transfer and validation of analytical procedures professionally and according to timelines.
Ensure ready to state activities in the MBQC lab.
Collaboration in the solution of MBQC problematic and / or questions (quality problems, government inquiries, etc.).
Supporting of laboratory employee during troubleshooting activities.
Efficient communication: Informing the MBQC head in a timely manner regarding ongoing business activities, deviations, and problems within the team.
Responsible for writing and revision of standard operating procedures (SOPs) and instructions (Wis) professionally and according to timelines.
Responsible for SME review and approval of methods, plans, protocols and reports, gap assessments
Education & Experience:
Degree (Master or higher) in the Microbiology or Life Science Area
At least 5 years experience in microbiological laboratories including experience in a regulated GMP environment.
Knowledge, Abilities:
Extensive knowledge of microbiological testing techniques (bioburden, endotoxin, qPCR) and laboratory best practices
Strong knowledge of cGMP requirements, method validation/verification, and documentation standards (SOPs, WIs)
Ability to troubleshoot microbiological issues, support investigations, and collaborate in cross-functional teams
Fluent English (written and spoken), German is a plus
What We Offer:
Compensation
Competitive Pay
Performance Related Bonus where eligible
Annual merit performance-based increase