CSV Specialist (m/f/d)

Ihre Aufgaben:
• Support and interface with process owners of systems and take part in daily activities upon request (provide technical and statistical support)

• Execute and documents Equipment & Software validation
• Oversee validation and qualification activities executed by analysts, provide training and support
• Ensure 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

Ihre Qualifikationen:
• Master’s in engineering, Computer Science, or related technical field
• Solid validation experience in the pharmaceutical industry
• 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
• Ability to identify and communicate risks in area of responsibility and across the site
• Fuency in English (C1) and French (C1)

Ihre Vorteile:
• Long-term planned project
• Dynamic environment
• Continuous support during the assignment
• Individual all-round care: Support throughout the entire application phase

Projektdauer: 12 MM++


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