Commissioning and Qualification Engineer

vor 1 Monat


Bern, Schweiz Randstad Vollzeit

For our client, a pharmaceutical company based in Bern, we are seeking a highly skilled Commissioning and Qualification Engineer for a 6-month contract position to support a capital expenditure (CAPEX) project.

As a Commissioning and Qualification Engineer, you will play a crucial role in ensuring the successful commissioning and qualification of facilities, systems, and equipment in compliance with applicable regulations and industry standards.

General Information:

  • Start date: ASAP (no later than 2.04.2024)
  • End date: 6 months
  • Workplace: Bern
  • Workload: 100%



    Key Responsibilities:
     

    • Support the overall commissioning and qualification activities for the 6-month project.
    • Collaborate with project stakeholders to develop commissioning and qualification plans, protocols, and reports.
    • Execute commissioning activities, including system turnover verification, alignment checks, functional testing, and documentation of results.
    • Perform qualification activities, including installation and operational qualifications (IQ/OQ).
    • Work closely with cross-functional teams to coordinate and integrate commissioning and qualification activities within project timelines.
    • Identify and mitigate risks during the commissioning and qualification phase, ensuring compliance with regulatory requirements and safety standards.
    • Utilize industry best practices and standard operating procedures to conduct commissioning and qualification activities.
    • Collaborate with project team members to ensure documentation is completed accurately and on schedule.



      Qualifications and Skills:
       

      • Bachelor's or Master's degree in Engineering or a related field.
      • Minimum of 5 years of experience in commissioning and qualification activities in in pharmaceuticals or biotechnology industry.
      • Strong knowledge and understanding of GMP (Good Manufacturing Practice) guidelines and regulatory requirements.
      • Experience in developing and executing commissioning and qualification plans, protocols, and methodologies.
      • Proficient in conducting system turnover verification, functional testing, and documentation of results.
      • Familiarity with qualification activities such as IQ/OQ.
      • Excellent problem-solving and analytical skills, with the ability to identify and resolve issues proactively.
      • Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
      • Detail-oriented, with exceptional organizational skills and the ability to manage multiple tasks and priorities simultaneously.
      • Availability to commit to a 6-month contract duration.
      • Business fluency in English, German language is a plus


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