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

<p></p><h2>About the role:</h2><p>The Team Computer Software Assurance ensures that applications developed in Digital Operations – Manufacturing IT are validated according the significant regulations and guidelines. Therefore the team operates a validation support tool (Polarion by Siemens) to support the development team in the validation process. In addition, the team fosters to follow the Fresenius Kabi QA principles in development activities.</p><p></p><h2>Your key responsibilities:</h2><p></p><ul><li>Support and validation guidance in validation projects of computerized systems according Computer Software Assurance (CSA) method as validation team lead (Validation Manager).</li><li>Support of the development teams in using a digital validation support tool (Polarion from Siemens) in validation projects.</li><li>Support and preparation of respective procedures and / or work instructions to support qualification and validation of computerized systems.</li><li>Auditing of software vendors and suppliers.</li><li>Review and auditing of GMP-compliant qualification and validation of corporate computerized systems as relevant and used in Digital Operations department.</li><li>Training of development teams in CSA and general validation principles within Digital Operations department.</li><li>Continuous improvement of CSA validation process as implemented in Digital Operations department.</li><li>Assure that computer software validations are done compliant and in consistency with relevant regulations and guidelines.</li><li>Assure that QM principles are followed in validation projects.</li><li>Escalation if CSA principles are disobeyed.</li><li>Re-qualify / re-audit software vendors and supplier to maintain their qualified status.</li></ul><p></p><h2>Your skills and experiences:</h2><h2></h2><ul><li>Academic degree (Master or comparable degree).</li><li>Profound experience in computerized system validation / computer software assurance.</li><li>Good knowledge of EU GMP Annex 11, US FDA 21 part 11 and GAMP 5.</li><li>Knowledge and understanding of corporate SOPs and Wis related to computer software validation and Quality and Risk Management.</li><li>Good software knowledge (Service Now / Polarion / Office) and basic knowledge of QM principles.</li><li>Proactive working and prioritizing tasks according to the requirements of the validation project.</li><li>Critical, creative and problem-oriented thinking in validation projects.</li><li>Team player with appropriate soft skills as well as good leadership skills, high motivation, good in decision-making and reliable.</li><li>Experience and readiness to work in multi-cultural and changing teams.</li><li>Good presentation and problem-solving skills.</li><li>Excellent English language skills.</li><li>Global travelling readiness.</li></ul><p></p><h2>Why join us?</h2><p><span>At Fresenius Kabi, you’ll contribute to something meaningful: delivering life-saving therapies to patients around the world. As part of a global transformation, you will work in a highly visible, impactful role with the opportunity to shape how we manage software development and delivery. You will join a diverse and dynamic team in a collaborative environment where your expertise will help drive innovation, efficiency, and quality across our digital landscape.</span></p>