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Computer system validation engineer/ csv engineer (m/w/d)

Schachen
nemensis ag
Inserat online seit: Veröffentlicht vor 5 Std.
Beschreibung

Computer System Validation Engineer (m/w/d) Ready to validate the future of pharmaceutical innovation? - Duration: 6 months - Location: Schachen, Switzerland - Type: Temporary position - Salary: CHF 8900 monthly gross About Our Client For our client, a leading global pharmaceutical and life sciences company with a strong presence in Switzerland, we are seeking a skilled professional. This innovative organization is renowned for developing breakthrough therapies and maintaining world-class research and development facilities that set industry standards in analytical sciences and quality assurance. Your Responsibilities - Oversee qualification processes for analytical instrumentation and computer systems within a regulated GMP laboratory environment - Execute system validation activities following SDLC (Software Development Life Cycle) methodologies in close collaboration with IT and site validation teams - Coordinate equipment lifecycle management, including procurement, installation, maintenance, upgrades, and decommissioning of laboratory instruments - Manage analytical metrology programs by scheduling and coordinating calibration maintenance services according to documented timelines and business requirements - Develop and maintain technical documentation, including SOPs, change controls, and periodic review documents for equipment and systems - Conduct initial troubleshooting and provide technical support for analytical laboratory instrumentation issues - Monitor and evaluate alarms from controlled-temperature units such as stability chambers and other critical laboratory equipment - Support deviation investigations and participate in CAPA management processes to ensure continuous improvement Your Profile - Technical education (apprenticeship) in biotech, pharmaceutical industry, IT, or related fields, OR a university degree in analytical chemistry, biotechnology, biochemistry, or similar disciplines - Proven experience in Computer System Validation (CSV) or Commissioning/Qualification activities - Strong communication skills in English (B1 level) and German (B2 level), both written and oral - Excellent documentation abilities with meticulous attention to detail when creating technical documents - Independent working style combined with strong teamwork capabilities in cross-functional, dynamic environments - GMP laboratory experience and familiarity with pharmaceutical quality standards are highly advantageous - Knowledge of Change Management principles, deviation handling, and CAPA processes is a plus - Technical affinity for equipment maintenance and IT-related software systems Benefits with Nemensis - Nemensis AG is your specialized personnel recruiter in the Life Sciences sector with headquarters in Basel - Comprehensive consultation and support throughout the application process by our consultants - Access to a large customer network and exciting positions in Northwestern Switzerland - Fast and uncomplicated entry through individual guidance and consultation in the application process Let's Connect! At nemensis ag, we've already connected thousands of candidates with their dream jobs, giving them the opportunity to develop further or re-enter the job market. What can we do for you and your career today? Get in touch with us! Are you ready to take on this exciting challenge as a Computer System Validation Engineer (m/w/d) in Schachen? We look forward to receiving your application! Contact Branche: Pharma-Industrie Funktion: Ingenieurwesen/Planung Anstellungsart: Befristeter Vertrag

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