Senior Validation Expert for Computerized Systems (m/f/d)

About the role

The Computer Software Assurance team ensures that applications developed in Digital Operations – Manufacturing IT are validated according to the significant regulations and guidelines. It uses a validation support tool (Polarion by Siemens) to support the development team and promotes Fresenius Kabi QA principles in development activities. The role acts as validation team lead (Validation Manager) for computerized systems.

Key responsibilities

• Provide support and validation guidance in computerized systems validation projects according to the CSA method, acting as validation team lead.
• Support development teams in using the digital validation tool (Polarion) in validation projects.
• Prepare procedures and/or work instructions supporting qualification and validation of computerized systems.
• Audit software vendors and suppliers, and review and audit GMP-compliant qualification and validation of corporate computerized systems used in Digital Operations.
• Train development teams in CSA and general validation principles.
• Continuously improve the CSA validation process and ensure validations comply with regulations and that QM principles are followed.
• Escalate violations of CSA principles and re-qualify or re-audit vendors and suppliers to maintain their qualified status.

Required profile

• Master's degree or comparable academic degree.
• Profound experience in computerized system validation / computer software assurance.
• Good knowledge of EU GMP Annex 11, US FDA 21 CFR Part 11 and GAMP 5.
• Knowledge of corporate SOPs and Wis on computer software validation, and of Quality and Risk Management.
• Experience and readiness to work in multi-cultural, changing teams; excellent English; willingness to travel globally.

Required skills

• Software tools: ServiceNow, Polarion, Office.
• Basic knowledge of QM principles.
• Proactive task prioritization, critical and creative thinking, leadership and decision-making skills.