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.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.