Commissioning & Qualification Engineer
Commissioning & Qualification Engineer

Commissioning & Qualification Engineer

Luzern Vollzeit Kein Home Office möglich
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Overview

A leading pharmaceutical R&D organization in Switzerland is seeking a Commissioning & Qualification Engineer to join its Metrology & Validation function within an analytical laboratory environment. This role plays a key part in ensuring analytical equipment and computer systems remain in a continuous state of GMP compliance and inspection readiness.

The position offers strong development potential and close collaboration with cross-functional stakeholders at both local and global level.

Role details

Switzerland Recruitment Manager (Pharma & Med Device) – Commissioning & Qualification Engineer (100%)

Work model: On-site (limited hybrid flexibility)

Contract: Permanent, full-time

Key Responsibilities

  • Plan, coordinate, and execute commissioning, qualification, and validation activities for analytical equipment
  • Perform Computer System Validation (CSV), including SDLC activities, in collaboration with IT and Quality teams
  • Manage equipment lifecycle activities such as purchasing, maintenance, calibration, and decommissioning
  • Support analytical metrology programs and ensure calibration schedules are maintained
  • Author and maintain GMP documentation including SOPs, change controls, periodic reviews, and validation reports
  • Support deviation investigations, CAPA activities, and change management processes
  • Collaborate with laboratory teams to support site-wide projects and continuous improvement initiatives

Candidate Profile

Education:

  • Technical education or apprenticeship in pharmaceutical, biotech, IT, or related technical fields, or
  • University degree in analytical chemistry, biotechnology, biochemistry, or a related discipline

Experience & Skills:

  • Hands-on experience in Commissioning & Qualification and/or Computer System Validation (CSV)
  • Experience working in GMP-regulated laboratory environments
  • Strong documentation skills with high attention to detail
  • Ability to work independently and within cross-functional teams
  • Proactive, solution-oriented mindset with strong organizational skills
  • Fluency in English (minimum B1) and German (minimum B2)

Preferred / Advantageous:

  • Experience with controlled-temperature units, incubators, or stability chambers
  • Knowledge of change management, deviation handling, and CAPA processes
  • Experience in auditing and regulatory inspections
  • Technical affinity for laboratory equipment and IT-related systems

Working Conditions

  • Site-based role, 5 days per week
  • Home office possible on an ad-hoc basis, subject to operational needs
  • Candidates with longer notice periods will be considered

Seniority level

  • Entry level

Employment type

  • Contract

Industries

  • Pharmaceutical Manufacturing

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Kontaktperson:

CK QLS HR Team

Commissioning & Qualification Engineer
CK QLS
Standort: Luzern
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