Computer System Validation (CSV) Expert
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
