Senior IT Validation Engineer, Quality and Laboratory Systems
Senior IT Validation Engineer, Quality and Laboratory Systems
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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:
Masters 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. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
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.
Date Posted
11-Jun-2025Closing Date
17-Jun-2025Alexion 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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.
Required Experience:
Senior IC
Employment Type
Full-Time
