Execution Engineer for Validation Protocols

vor 4 Wochen


Visp, Schweiz Randstad Vollzeit

Job Title: CSV Execution Engineer

Job Description:

We are seeking a skilled CSV Execution Engineer to support our projects in the execution of validation protocols. This role involves collaborating with various teams to ensure compliance with CQV/CSV processes and maintaining project timelines.

Key Responsibilities:

  • Participate in system classification assessments and collaborate with CSV subject matter experts.
  • Create and execute CSV documents following standard operating procedures and guidelines.
  • Engage in FAT and SAT testing and create detailed validation protocols and reports.
  • Work closely with CSV Regional Leads or CQV Leads to support operational teams on technical changes and life cycle activities.
  • Ensure compliance with CQV/CSV guidelines, local procedures, and detect any gaps in compliance.

Required Qualifications:

  • Technical degree in engineering or applied sciences, or equivalent experience.
  • Experience in regulated industries or engineering environments, particularly in hands-on roles.
  • Basic knowledge of ISPE GAMP5, ASTM guidelines, and regulatory requirements for GxP.
  • Familiarity with biologics (mammalian, CGT) or chemical manufacturing technologies is highly desirable.
  • Understanding of automation and data flow processes, as well as data integrity principles (ALCOA+).

Skills and Competencies:

  • Strong analytical skills and experience working with complex data sets to support decision-making.
  • Excellent collaboration skills, with the ability to work in a matrix environment.
  • Proficiency in English, with a strong command of German (reading and writing).
  • Ability to prioritize tasks effectively and work both independently and within a team.


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