Commissioning and Qualification Engineer

vor 2 Monaten

Bern, Schweiz Randstad Vollzeit

For our client, an international company based in Bern, we are seeking a highly skilled Commissioning and Qualification Engineer for a 6-month contract.
 

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 manufacturing production and QC in compliance with applicable regulations and industry standards.

 

General Information:

 

  • Start date: ASAP
  • End date: 31.12.2024
  • Extension: possible
  • Workplace: Bern
  • Workload: 100%

     

     

    Key Responsibilities:
     

    The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:

    • (re-) qualification of production/QC equipment is performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
    • Write/review Commissioning & Qualification plans and reports.
    • Execution of RQ, IQ, OQ including protocol deviations, investigation, and corrective action activities
    • Plan and track execution of commissioning & qualification activities/documentation versus project(s) timelines.
    • Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification documentation)
    • Coordinate and execute commissioning & qualification activities in collaboration with internal and external partners
    • Coordination and oversight of external suppliers

      Your Profile:

       

      • Bachelorâs or Masterâs degree in Engineering or a related field.
      • Minimum of 3 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.
      • 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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