Scientist – QC Lab Systems & CSV (GMP)
Work Schedule
Standard (Mon\-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Join Thermo Fisher Scientific at our Lengnau site as a Scientist – QC Lab Systems \& CSV (GMP) in the Quality Control department. In this role, you will contribute to ensuring GMP compliance, data integrity, and operational excellence of electronic laboratory systems and analytical equipment. You will support the lifecycle management, validation, and continuous improvement of QC applications, directly contributing to reliable product quality and regulatory compliance.
Key Responsibilities
- Ensure lifecycle management of QC applications (e.g., SM LIMS, Empower, LabX, Tiamo), including administration and first\- and second\-level support
- Support qualification of analytical equipment, including Computerized System Validation (CSV) of electronic laboratory systems
- Coordinate activities between QC, QA, IT, and external vendors for system implementation, maintenance, and enhancements
- Create, review, and maintain GxP lifecycle documentation to ensure compliance with regulatory requirements
- Ensure compliant storage, handling, and integrity of laboratory raw data
- Support QC laboratories in deviation, change controls, and troubleshooting activities
- Participate in gap assessments and support actions to ensure inspection and audit readiness; actively contribute during audits
- Contribute to automation and digitalization initiatives, including implementation of automated data flows
- Collaborate with local and global teams to support continuous improvement (PPI) and system optimization
- Ensure adherence to cGMP, quality, and EHSS requirements
Bachelor’s or Master’s degree in Life Sciences (e.g., Chemistry, Biochemistry, Microbiology, Physics) or an IT/Automation background with experience in a GMP\-regulated environment or similar education with experience in maintaining QC laboratory applications.
Experience
Minimum 3\+ years of experience in a GMP\-regulated laboratory or pharmaceutical environment. Hands\-on experience with Computerized System Validation (CSV) and electronic laboratory systems is required. Experience with systems such as LIMS, Empower, Tiamo, LabXChromeleon, or similar platforms is advantageous. Basic knowledge of IT systems, databases is beneficial.
Skills \& Competencies
- Strong understanding of GMP, data integrity, and regulatory requirements for computerized systems
- Structured, detail\-oriented, and risk\-based approach to work
- Ability to work independently while collaborating across cross\-functional teams
- Strong communication, organization, and prioritization skills
- Customer\-focused mindset with a proactive approach to problem solving
- Interest in digitalization, automation, and continuous improvement (PPI)
- Fluency in technical English; German language skills are an advantage
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