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.
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📌 (Senior) Validation Expert For Computerized Systems (M/F/D)
🏢 100055 Fresenius Kabi Deutschland
📍 Madrid