Scientist– QC Lab Systems&CSV (GMP) (M&W), Lengnau

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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