Role at a glance
- Salary
- Not Disclosed
- Location
- Lengnau, Switzerland
- Work arrangement
- On-site
- Employment
- Full-time
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About the role
Original posting provided by Thermo Fisher Scientific
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
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.