Senior Scientist, Analytical Instrument Qualification & Validation (QC)

Work Schedule

Environmental Conditions

Job Description

Are you ready to make a meaningful impact in the world of science? Join Thermo Fisher Scientific as a Senior Scientist, Analytical Instrument Qualification & Validation within our Quality Control organization at the PSG site in Lengnau. In this role, you will play a critical part in ensuring GMP compliance and operational excellence, directly supporting our mission to enable our customers to make the world healthier, cleaner, and safer.

As a Senior Scientist in Services and Support Quality Control, you will serve as a subject matter expert for the qualification, validation, and compliance status of analytical instrumentation used in QC. You will ensure that all analytical equipment meets regulatory and health authority requirements and remains in a state of continuous compliance.

Key Responsibilities:

• Lead the (re-)qualification of existing and new analytical equipment in a GMP-regulated QC environment.

• Act as Subject Matter Expert (SME) for analytical equipment qualification status reviews and lifecycle management.

• Ensure validation and technical oversight of analytical methods, in alignment with regulatory expectations.

• Review and approve maintenance, calibration, and qualification documentation for analytical instruments.

• Lead and support Computer System Validation (CSV) activities related to analytical equipment.

• Support maintenance activities for analytical equipment to ensure continuous GMP compliance.

• Serve as SME for analytical methods, providing expert support to QC laboratories during deviations, OOS investigations, troubleshooting, and continuous improvement activities.

• Collaborate cross-functionally with QC, QA, Engineering, IT, and external vendors to ensure compliant and robust analytical systems.

Who We Are Looking For:

Education

• Bachelor’s or Master’s degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, or a related scientific discipline.

• Equivalent professional experience in a GMP-regulated environment will be considered.

Experience

• Minimum 5 years of experience working in a GMP laboratory environment within the pharmaceutical or biopharmaceutical industry.

• Demonstrated expertise in qualification and validation of analytical equipment.

• Experience supporting analytical methods and laboratory investigations is highly desirable.

• Proficiency in technical English is required, German skills are an added benefit.

Skills & Abilities

• Strong commitment to quality, compliance, and data integrity.

• High attention to detail and a structured, risk-based approach to work.

• Ability to work independently while collaborating effectively across functions.

• Excellent communication, organization, and prioritization skills.

• Strong interest in digitalization and modernization of analytical systems.

• Motivation to continuously develop technical and regulatory expertise.