As a Subject Matter Expert (SME) in Computerized System Validation (CSV), you will provide specialized knowledge and expertise across Production, Quality Control (QC), and IT systems (including eQMS, LIMS, ERP, etc.). You will be instrumental in ensuring system validation, maintaining regulatory compliance, and driving continuous improvement throughout the system lifecycle. You will be accountable for ensuring that systems are designed, validated/qualified, and maintained in strict accordance with GAMP 5 guidelines, relevant regulatory requirements, and data integrity principles. Your role will be critical in performing thorough reviews and assessments, and in making informed technical decisions based on a strong scientific understanding of processes and products.

Domaines : CSV for Production, QC and IT System (eQMS, LIMS, ERP,..)

** Onsite presence in VISP is a must **

Your responsibilities will include:

• Assist in the development of user requirements providing inputs
• Provide input to functional specifications.
• Evaluate prototypes and assist in system demonstrations to cover CSV topics
• Participate in cross-functional teams for project planning. Offer expertise in specific areas related to the system, such as technical, regulatory, or operational domains.
• Author or Support the creation of validation plans, protocols, and reports. Select appropriate test methods and execute verification tests or supervise the execution if executed by external person (supplier)
• Provide input during system design and development to ensure compliance and functionality.
• Participate in or oversee the execution of validation activities such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Review /Analyze executed tests to ensure they meet predefined acceptance criteria. Address incidents or changes during CSV process and evaluate measure to be in place
• Assist in troubleshooting and resolving validation issues related to system functionality and compliance.
• Provide ongoing technical support and expertise to ensure system reliability and integrity.
• Support internal teams (Process Owner and System Owner) during audits and inspections in their domain of competence. Prepare for audits and inspections by ensuring all documentation and processes relative to their domain are in place and compliant.
• Continuous Improvement : Identify opportunities for process and system improvements.
• Incorporate feedback from users and audits into system enhancements.
• Support system updates and upgrades, ensuring continued compliance and performance.

We are looking for someone with,

• Minimum 5-7 years of demonstrable CSV experience within both Production and Laboratory environments.
• In-depth knowledge of GAMP 5 principles and comprehensive understanding of Data Integrity.
• Proven experience as a Subject Matter Expert (SME) supporting regulatory inspections and customer audits.
• Strong understanding of Cloud-based systems, with experience in Agile, ERP, MES, SCADA, or Trackwise as a major plus.
• Excellent communication skills in English and proficiency in German (for documentation review) are required.
• Strong collaborative mindset with the ability to work both individually and in a team-oriented environment.
• Highly organized, autonomous, and flexible, with a pragmatic approach to problem-solving and managing shifting priorities.

We offer you a dynamic environment where you can make a meaningful contribution, collaborate with exceptional minds, and develop your full potential.
 
This is what sets ten23 apart:

• A valuable and effective opportunity for professional development in an inspiring environment.
• Flexible working arrangements and an environment with an open culture and a diverse workforce.
• The opportunity to work with and learn from highly qualified and experienced employees.
• Our culture of learning and self-development offers a wide range of continuing education opportunities.
• A competitive pension plan, annual bonuses, and other financial and non-financial benefits.

At ten23, we believe in personal responsibility and mutual trust. Therefore, we offer our employees as much flexibility as possible and keep any bureaucracy to a minimum, while ensuring compliance with all applicable laws.

For further information and clarifications, please contact Amrith ( amrith.kiran@ten23.health ) from our talent team!