For our customer located in Neuchatel/Switzerland we are currently looking for a:  Computer System Validation Expert (m/f/d)

Tasks & Responsibilities

As a CSV (Computer System Validation) Engineer for a Labware LIMS (Laboratory Information Management System), your main tasks may include: 

• System validation: You will be responsible for conducting validation activities in accordance with regulations and standards such as FDA (Food and Drug Administration) regulations or ISO (International Organization for Standardization) standards. This includes writing validation protocols, executing tests, documenting results, and resolving identified issues.
• System lifecycle management: You need to ensure ongoing maintenance and updates of the Labware LIMS system. This may involve managing software patches, applying updates, integrating new features, and coordinating with software vendors.
• User training and support: You will need to train laboratory users on how to use the Labware LIMS system. You will also provide ongoing technical support, address user questions, troubleshoot issues, and ensure the system’s smooth operation.
• Change management: You will be responsible for managing changes and updates to the Labware LIMS system. This may involve assessing the impact of changes, planning and executing additional validation tests, and coordinating with stakeholders to ensure appropriate implementation of changes.
• Documentation: You need to document all activities related to the validation and qualification of the Labware LIMS system. This includes writing validation reports, user manuals, administration guides, and any other necessary documentation.

Must Haves

• Bachelor’s or Master’s degree in a relevant field such as Computer Science, Biomedical Engineering, or Life Sciences.
• Knowledge of regulatory requirements and standards related to computer system validation, such as FDA 21 CFR Part 11, GAMP (Good Automated Manufacturing Practice), and ISO 13485.
• Strong understanding of laboratory processes and workflows, particularly in the context of information management, sample tracking, and data analysis.
• Excellent analytical and problem-solving skills to identify and resolve validation issues and system-related challenges.
• Attention to detail and ability to meticulously document validation activities, protocols, and results.
• Good project management skills to plan and execute validation projects effectively.
• Effective communication and collaboration skills to work with cross-functional teams, including laboratory personnel, IT professionals, and system vendors.
• Strong organizational skills to manage multiple tasks and prioritize work accordingly.
• Proficiency in English is typically required, as it is the common language used in scientific and technical communication.
• Solid knowledge of computer systems and software used in the context of laboratory information management, such as Labware LIMS or similar systems.
• Familiarity with database management and SQL (Structured Query Language) for data extraction and manipulation.
• Understanding of programming concepts and scripting languages (e.g., Python) can be beneficial for system customization and automation.
• Knowledge of validation tools and methodologies, as well as experience with validation documentation software, may be advantageous.

Did we catch your interest?

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.