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

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, 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

Thermo Fisher Scientific is an equal opportunity employer and values diversity and inclusion in the workplace.