CSV and Lab Informatics Specialist – 5324 ADA

Our client,a pioneer in Drug Discovery and Development, is looking for a CSV and Lab Informatics Specialist with technical skills, strong knowledge and skills in laboratory computer science (PC, Windows operating system, laboratory applications and network Active Directory) based in Basel, Switzerland.

CSV and Lab Informatics Specialist – 5324 ADA

Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.

Our client is looking for a CSV and Lab Informatics Specialist with technical skills, strong knowledge and skills in laboratory computer science (PC, Windows operating system, laboratory applicationsand networkActive Directory). In addition, GxP and non-GxP activities in the laboratory must be known. It is a combination of laboratory and technical knowledge. There is a strong focus on the soft skills mentioned.

Main Responsibilities:

• Implementation of computerized analysis systems and execution of computer system validations
• Support in the evaluation, planning and device qualification and validation of computerized analysis systems in cooperation with the laboratory functions
• CSV change management for the computer systems being looked after
• Implementation of the CSV and IT guidelines in accordance with the valid regulations in the GMP and non-GMP areas
• Support of the laboratory areas in laboratory IT, application management (GMP & non-GMP) and CSV matters
• Maintenance of supervised CSV systems & maintaining the functionality over the lifecycle of these systems
• Archiving and backup of electronic data of the CSV systems
• Hardware and software updates/upgrades of the CSV systems
• System administration of the supervised computer systems in the OS and applications
• Troubleshooting of computerized CSV systems (computer hardware , software and connected instruments)
• Technical further development of new computerized systems in order to be able to use them in the GMP environment

Qualifications and Experience:

• Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
• Completed technical vocational training as a laboratory technician or in a laboratory environment with pronounced CSV and laboratory computer science knowledge
• At least 3 -5+ years of experience in the validation and qualification of computer systems (CSV) in the pharmaceutical GxP and non-GxP environment, preferably with laboratory IT systems
• Ideally experience in the support, planning, implementation and operation of computerized analytical measurement systems and their software
• Very good knowledge of Windows operating systems (e.g. Windows 10, Windows Server)
• Fluent written and spoken German and good knowledge of English (at least B2 level)
• Independent completion of tasks and work in projects as well as independent organization and working methods according to specifications
• Good teamwork and integration with strong communication skills
• High level of independence and reliability with flexibility and adaptability
• Innovative and solution-oriented behavior as well as willingness to learn and openness to new things
• Experience in the qualification of measuring devices is an advantage
• Programming knowledge is an advantage
• Experience in incident management is an advantage