CSV Execution Specialist

vor 4 Wochen

Visp, Schweiz Randstad Vollzeit
Job Description

At Randstad, we are seeking a skilled CSV Execution Specialist to support our projects in the accurate execution of validation protocols. In this role, you will collaborate closely with various teams to ensure that timelines are met and that compliance with Lonza's CQV/CSV processes is maintained throughout the project lifecycle.

Key Responsibilities:

  • Participate in system classification assessments and collaborate with CSV subject matter experts.
  • Create and execute CSV documents following Lonza's standard operating procedures and guidelines, ensuring compliance with good documentation practices.
  • 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 that all Global Engineering projects comply with Lonza's CQV/CSV guidelines, local procedures, and continuously work to detect and resolve any gaps in compliance.

Required Qualifications:

  • Technical degree (Bachelor's level) 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.

At Randstad, we are committed to building a healthy, sustainable future. If you are motivated, adaptable, and ready to contribute to a dynamic environment, we would love to hear from you.

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