Senior IT Validation Engineer, Quality and Laboratory Systems

Job Description

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 Alexions 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: Bachelors 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 At AstraZenecas 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 others successes and take pride in giving back to our communities. Here, your career is more than just a path; its 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. 11-Jun-2025 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 accommodations@Alexion.com . Alexion participates in E-Verify.