Scientist – QC Lab Systems & CSV (GMP) (M&W)
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
Qualifications:
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, LabX Chromeleon, 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
Thermo Fisher Scientific is an equal opportunity employer and values diversity and inclusion in the workplace.
Location: Lengnau, Switzerland.
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