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Commissioning and qualification engineer

Luzern
nemensis ag
EUR 80’000 - EUR 100’000 pro Jahr
Inserat online seit: Veröffentlicht vor 16 Std.
Beschreibung

Commissioning & Qualification Engineer (m/f/d)
Ready to ensure quality and compliance in cutting‑edge biopharmaceutical development?

Duration: 09.01.2026 to 31.07.2026

Employment Type: Temporary Position

About Our Client
For our client, a globally leading biopharmaceutical company specializing in the development and testing of innovative biological medicines, we are seeking a motivated Commissioning & Qualification Engineer (m/f/d). This state‑of‑the‑art research and development facility in the Lucerne region plays a crucial role in the global network, providing analytical services and manufacturing clinical trial drugs for worldwide studies while operating one of only three forensic laboratories globally.

Your Responsibilities

Oversee and execute equipment qualifications, validations, and system lifecycle management activities including procurement, maintenance, and decommissioning within GMP‑regulated analytical laboratories

Conduct system validation activities following SDLC methodology in close collaboration with IT teams and site validation units

Manage analytical metrology by coordinating calibration maintenance services with Laboratory Asset Management Program coordinators to meet documented schedules and ad‑hoc business requirements

Coordinate cross‑functional teams to qualify new analytical instrumentation and laboratory equipment

Monitor and evaluate alarms from controlled‑temperature units such as stability chambers and other critical lab equipment

Develop and maintain SOPs, change controls, and periodic review documentation for equipment and instruments

Support and author deviation investigations and contribute to site‑wide projects related to Metrology & Validation

Your Profile

Technical education (apprenticeship) in biotech, pharmaceutical industry, IT, or related fields, OR technical training in industrial equipment management and maintenance, OR university degree in analytical chemistry, biotechnology, biochemistry, or related disciplines

Proven experience in Commissioning/Qualification and/or Computer System Validation (CSV)

Strong communication skills in English (B1 level) and German (B2 level), both written and oral

Excellent documentation abilities with meticulous attention to detail on technical documents

Demonstrated capacity for independent work and collaborative problem‑solving within cross‑functional teams

Ability to deliver on tight timelines in a dynamic, fast‑paced environment

Experience with GMP laboratories and thorough understanding of GMP policies and procedures is advantageous

Familiarity with controlled‑temperature units, incubators, Change Management principles, and Deviation/CAPA management is a plus

What We Offer

Nemensis AG is your specialized personnel recruiter in the Life Sciences sector, based in Basel

Comprehensive consultation and support throughout the application process by our experienced consultants

Access to an extensive client network and exciting opportunities in Northwestern Switzerland

Fast and straightforward onboarding through individual guidance and advisory during the recruitment process

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