Role OverviewThe Team Computer Software Assurance ensures that applications developed in Digital Operations – Manufacturing IT are validated according to significant regulations and guidelines. Therefore the team operates a validation support tool (Polarion by Siemens) to support the development team in the validation process and fosters the following:
- Supports validation projects of computerized systems using the Computer Software Assurance (CSA) method as validation team lead (Validation Manager).
- Provides guidance to development teams on using Polarion in validation projects.
- Prepares procedures and work instructions to support qualification and validation of computerized systems.
- Conducts auditing of software vendors and suppliers.
- Reviews and audits GMP-compliant qualification and validation of corporate computerized systems used in the Digital Operations department.
- Trains development teams in CSA and general validation principles within the Digital Operations department.
- Continuously improves the CSA validation process as implemented in the department.




- Ensures that computer software validations are compliant and consistent with relevant regulations and guidelines.
- Ensures that QM principles are followed in validation projects.
- Escalates if CSA principles are disobeyed.
- Re‑qualifies / re‑audits software vendors and suppliers to maintain their qualified status.

Key Responsibilities
- Provide validation guidance in validation projects of computerized systems according to CSA as validation team lead (Validation Manager).
- Support development teams using Polarion in validation projects.
- Prepare procedures and work instructions to support qualification and validation of computerized systems.
- Audit software vendors and suppliers.
- 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 impro

📌 (Senior) Validation Expert for Computerized Systems (Barcelona)
🏢 100055 Fresenius Kabi Deutschland
📍 Barcelona