Commissioning & Qualification Engineer - II

  • Salary: 108 - 130'000 CHF gross
  • REF Number: 00056280
  • Consultant: Adrien Guimard
  • Contact: 0041 (0) 800 106 106
  • Date Published: 09.11.2023
  • Sector:
  • Location: Lucerne,
  • Discipline:

QLS are recruiting for a Commissioning and Engineer II to join a Global Biopharmaceutical company based in Lucerne on a 12 months contract.

The Qualification and Cleaning/Sterilization Validation Subject Matter Expert (SME) is a role within theValidation Unit team. This function leads/supervises qualification and Cleaning/Sterilization Validation projects. It is in the responsibility of this function to implement new systems and processes to a state of permanent inspection readiness.Main responsibilities include:

  • Lead/Supervision of site projects related to Qualification, CSV, Cleaning/Sterilization Validation: o Lead coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations. o Responsible for the development / review / improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation: such as SOPs, qualification/validation documents, reports. o Responsible for compliance deliverables and technical deliverables related to qualification and validation.

  • Act as an SME and point of contact for Qualification and Cleaning/Sterilization Validation at the entire WAG Site. o Represent Validation Unit atboth local site meetings and cross functional global meetings. o Represent Qualification and Cleaning/Sterilization Validation aspects during inspections. o Provide direction, give guidance and implement procedures in agreement with VU Lead.

  • Responsible for the area’s implementation of process changes, and root cause investigation of deviations.

  • Responsible for the evaluation of innovative equipment / technologies with respect to Qualification, CSV, Cleaning/Sterilization Validation, reviewing user requirements.
  • Identify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation – simplifying processing to ensure compliance, while decreasing implementation effort.

Your qualification:

  • University degree preferable in Engineering, Biology, Microbiology.
  • Minimum 5 years of experience in pharmaceutical environment with minimum 3 years of experience in computer system validation, equipment qualification and cleaning validation.
  • Excellent know-how of current GMP regulations and industrial standards.
  • Extensive experience in Auditing and Compliance within pharmaceutical industry.
  • Change and Deviation Management experience.
  • Strong Project Management skills: organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines, and ensuring on-time delivery. Can define and lead projects to support improvement, implementation or remediation.
  • Strong communicationskills: Plans and delivers ideas and information to others in a clear and impactful manner.


For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email Please could yousend any correspondence in English. Please quote job reference 56280 in all correspondence.

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