Quality Engineering Specialist

CTC Resourcing Solutions AG in Stein, CH, seeks a mid-level Quality Engineering Specialist for a full-time, on-site role. The position involves overseeing quality aspects of qualification activities for technical facilities and systems, supporting qualification strategy development, and coordinating cross-departmental efforts during project initiation.

This role is responsible for all quality-related aspects of daily qualification activities on technical facilities, equipment, and systems. It supports the development of qualification strategies and facilitates coordination between departments during project initiation, while also keeping the Global Engineering Front End Group informed of relevant industry trends.

Responsibilities

• Manage all quality-related tasks for daily qualification activities on technical facilities, equipment, and systems.
• Organize and lead coordination meetings between departments during the project initiation phase to align on deliverables and activities.
• Review and approve User Requirement Specifications, Technical Specifications, P&IDs, and Risk Assessments.
• Evaluate and approve design documentation.
• Approve qualification documents as applicable.
• Contribute to the development and ongoing improvement of qualification strategies.
• Share relevant industry developments and trends with the Global Engineering Front End Group.

Requirements

• Must hold a Swiss/EU citizenship or a valid working/residency permit.
• Prior experience in biotechnology or pharmaceutical environments.
• Minimum of 3 years of experience in facility design or related projects.
• Background in QA qualification and engineering processes.
• Understanding of facility design principles.
• Familiarity with CAPEX project initiation procedures.
• Proactive attitude with strong communication skills and the ability to collaborate in multidisciplinary teams.
• Fluent in English, both spoken and written.

Nice to have

• Experience with risk analysis methods.
• German language skills are beneficial but not required.
• Familiarity with the Kneat system is advantageous.
• Demonstrated independent, proactive, and pragmatic work style.