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.

Integral travelling readiness.

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