Description

For our client, an international company based in Neuchâtel, we are looking for a Computer System Validation (CSV) Expert 

General Information:

• Start date: ASAP (flexibility until mid of October)

• Duration: 12 months

• Workplace: Neuchâtel

• Workload: 100% 

  Your responsibilities:

  The job holder is accountable for life cycle management activities of systems used in the QC Laboratories.

  • Analytical Instrument Qualification

  • Computerized System Validation

    In addition, the job holder also supports the Data Integrity deployment.

    • Validation and Qualification Activities:

    • Author specification documents (URS-FS-SDCS).

    • Author plans, protocols, and reports

    • Execute and document Equipment & Software validation.

    • Oversee validation and qualification activities executed by analysts, provide training and support.

    • 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 change.

    • Provide technical assessments on protocols deviations and investigations.

    • Serve as SME for internal technical group discussions.

    • Quality Control Support Activities:

    • Support and interface with process owners of systems.

    • Participate to daily activities upon request (provide technical and statistical support) 

      Your profile:

       

      • Master’s in engineering, Computer Science, or related technical field

      • Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry

      • Fluent in French and English (C1 written and spoken)

      • Extensive experience with validation life cycle requirements for cGMPs 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 cGMPs operations

      • Provides input on project execution and acts as a consultant to management.

      • Authors and reviews protocol and reports as per established company guidelines and SOPs.

      • Identifying and communicating risks in the area of responsibility and across the site.

      • A proven ability to lead cross functional teams and deliver on tight timelines

      • Demonstrate flexible and innovative approach to work

      • Excellent collaboration skills and teamwork mindset

      • Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problems solving

      • Ability to challenge the status quo with a continuous improvement mindset

      • Ability to work independently in a fast-paced environment

      • Ability to manage multiple priorities and know when to escalate issues for resolution