Senior It Validation Engineer, Quality And Laboratory Systems

Job Title Senior IT Validation Engineer Quality and Laboratory Systems Work Location Manyata Tech Park Bangalore India Work Schedule Three days on-site two days remote 3 2 Career Level D3 - Individual Contributor position Introduction to role Are you ready to make a difference in the world of rare diseases At Alexion AstraZeneca Rare Disease we are committed to transforming lives by innovating and delivering meaningful solutions for patients and families Our diverse team is the backbone of our success driving breakthroughs that matter Join us in our mission to empower those affected by rare and devastating conditions Accountabilities As a Senior IT Validation Engineer you will play a pivotal role in ensuring the compliance and reliability of our GxP systems You will lead validation efforts that impact Alexion s Quality and Manufacturing Science and Analytical Technology MSAT functions Your expertise will be crucial in streamlining operations through lean digital solutions and processes Collaborate with external partners and vendors to oversee BAU service validation management IT support upgrades and enhancements for critical systems Essential Skills Experience Bachelor s degree in Computer Science Information Technology Science Engineering or a related field 8 years of experience in IT validation management within the GxP Quality and Laboratory Systems Domain Proficiency in risk assessment methodologies and validation approaches Strong knowledge of ITIL principles and IT service management best practices e g ITIL 4 certification Experience 1-3 years of Stakeholder Relationship and Communication Management Direct experience working with the following systems Laboratory Information Management Systems e g LabWare LIMS Lab Execution Systems e g Biovia ONE Lab LES Chromatography Data Systems e g Empower 3 CDS Document Management Systems e g Veeva Vault QualityDocs ZenQMS Quality Management Systems e g Veeva Vault QMS Sparta TrackWise QMS Validation Lifecycle Management Systems e g ValGenesis and Kneat Gx Scientific Data Management Systems e g Waters NuGenesis SDMS Computer Systems Validation and GAMP 5 extensive experience Knowledge of analytical instrument validation and USP 1058 Experience with automated testing tools and validation of cloud-based systems Proficiency in quality management processes and regulatory requirements Familiarity with IT security practices and their impact on system validation Desirable Skills Experience Master s Degree in Computer Science Information Technology Science Engineering or a related field Cloud Certification e g AW Azure Experience with continuous validation approaches Six Sigma or Lean certification Knowledge of emerging technologies like AI ML in regulated environments Customer focused with high enthusiasm and energy Excellent communication analytical and decision-making skills Self-starter with the ability to work independently Experience working with global multi-cultural teams When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing medicines In-person working gives us the platform we need to connect work at pace and challenge perceptions That s why we work on average a minimum of three days per week from the office But that doesn t mean we re not flexible We balance the expectation of being in the office while respecting individual flexibility Join us in our unique and ambitious world At AstraZeneca s Alexion division we champion diversity and foster an energizing culture where new ideas thrive Our commitment to inclusion ensures that life-changing innovations can come from anywhere We celebrate each other s successes and take pride in giving back to our communities Here your career is more than just a path it s a journey to making a difference where it truly counts Ready to make a difference Apply now to join our team We are an equal opportunity employer and value diversity at our company We do not discriminate on the basis of race religion color national origin sex gender gender expression sexual orientation age marital status veteran status or disability status We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request accommodation Date Posted 11-Jun-2025 Closing Date 17-Jun-2025 Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy including childbirth breastfeeding or related medical conditions parental status including adoption or surrogacy military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law Alexion provides reasonable accommodations to meet the needs of candidates and employees To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in E-Verify