Computer System Validation Specialist

vor 1 Monat


Neuenburg, Neuenburg, Schweiz CK Group Vollzeit
Job Title: Computer System Validation Expert

CK Group is seeking a highly skilled Computer System Validation Expert to join our team on a contract basis. The successful candidate will be responsible for ensuring the validation and qualification of laboratory systems used in the QC Laboratories of Neuchatel, Switzerland.

Key Responsibilities:
  • Author specification documents, plans, protocols, and reports for validation and qualification activities.
  • Execute and document equipment and software validation, and oversee validation and qualification activities executed by analysts.
  • Assure cGMP compliant and timely implementation and maintenance of validated status of systems.
  • Conduct/participate in risk assessments, root cause analysis, and investigations.
  • Identify, lead, and drive improvements or changes, and provide technical assessments on protocol deviations and investigations.
  • Serve as a subject matter expert for internal technical group discussions.
Requirements:
  • Master's degree in engineering, computer science, or a related technical field.
  • Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry.
  • Extensive experience with validation life cycle requirements for cGMP laboratory systems.
  • Experience with project management and/or leadership enabling cross-functional engagement to deliver project goals and timelines.
  • A thorough knowledge of DI requirements and standard regulations for cGMP operations.
What We Offer:

CK Group is a leading provider of contract staffing services, and we offer a competitive compensation package, including a salary range of CHF 80,000 - CHF 120,000 per year, depending on experience.

If you are a motivated and experienced Computer System Validation Expert looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].



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