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Qualification Engineer
Job in
4040, Basel, Kanton Basel-Landschaft, Switzerland
Listed on 2026-02-17
Listing for:
K-Recruiting Life Sciences
Full Time
position Listed on 2026-02-17
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
- Lead commissioning and qualification activities for clean utilities, process gases, and controlled rooms
- Define and execute sampling and monitoring strategies for utility and environmental systems
- Coordinate internal teams and external vendors for testing, commissioning, and analytical services
- Prepare and maintain qualification documentation such as protocols, acceptance criteria, and summary reports
- Perform GMP risk assessments for quality-critical infrastructure and cleanroom utilities
- Own deviations and corrective actions in collaboration with Quality functions
- Act as subject matter expert for changes, investigations, training, and interfaces with QC
- Establish routine monitoring, trending, and continuous improvement programs for utilities and environments
- Several years of experience in CQV, microbiology, and lifecycle management of clean utilities, rooms, and process gas systems
- Proven background in commissioning, qualification, and monitoring within GMP-regulated facilities
- Strong knowledge of compliance frameworks (e.g. EU GMP, FDA, ICH, ISO, GAMP)
- Structured, hands‑on, and solution‑oriented with strong communication skills
- Fluent in German;
English skills are an advantage
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