QC Software Specialist

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, No eye contacts allowed; prescriptive glasses will be provided, Office

Job Description

Are you ready to make an exceptional impact in the world of science? Join Thermo Fisher Scientific as a QC Software Specialist in our world-class Quality Control team based at our PSG Large Molecule site in Lengnau. Be a part of our ambitious mission to enable our customers to make the world healthier, cleaner, and safer through flawless execution and innovative solutions.

What will you do?

Discover Impactful Work:

The QC Software Specialist ensures that processes, analytical equipment, and related applications align with health authority requirements. Key responsibilities include:

• Managing the lifecycle of QC systems, providing first & second-level support to meet customer and health authority expectations.
• Participating in the qualification of analytical equipment, including Computer System Validation (CSV).
• Delivering timely support to QC lab units for the investigation and resolution of OOX, change controls, and deviations.
• Engaging in gap assessments and actions related to inspection/audit readiness for health authorities and customer audits, including active participation during such inspections.

• A Bachelor's or Master's degree in Molecular Biology, Chemistry, Biochemistry, Chemical Engineering, or a related field is required. Equivalent experience in these fields will also be considered.
• Alternatively, an IT/Automation background with proven experience in the pharma industry.

• Proficiency with applications of analytical equipment, including Computer System Validation (CSV)
• Familiarity with Lab Execution Systems such as SM LIMS, Chromeleon, Lab X, Empower, etc. is a plus
• Experience in a GMP laboratory environment including Computer System Validation (CSV) is a plus
• Technical English required, German is a plus.

• Passionate about the digitalization of systems.
• Proficient in working effectively across different functions.
• High attention to detail.
• Ability to work independently with excellent communication and prioritization skills.
• Strong desire to learn new skills and successfully implement them.