Role Overview

The 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 improve the CSA validation process.
- Ensure compliance of software validations with regulations and guidelines.
- Ensure QM principles are followed.
- Escalate when CSA principles are disobeyed.
- Re‑qualify / re‑audit software vendors and suppliers to maintain their qualified status.

Skills & Experiences
- Academic degree (Master or comparable).
- Profound experience in computerized system validation / computer software assurance.
- Good knowledge of EU GMP Annex 11, US FDA 21 part 11, and GAMP 5.
- Knowledge and understanding of corporate SOPs and Wis related to computer software validation and Quality and Risk Management.
- Good knowledge of ServiceNow, Polarion and Office, and basic knowledge of QM principles.
- Proactive working and prioritizing tasks according to validation project requirements.
- Critical, creative, and problem‑oriented thinking in validation projects.
- Team player with good soft skills, leadership skills, high motivation, decision‑making ability and reliability.
- Experience and readiness to work in multicultural and changing teams.
- Good presentation and problem‑solving skills.
- Excellent English language skills. xcskxlj
- General travelling readiness.

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