Senior AIT Quality Engineer

SeniorAIT Quality Engineer
Who we are
We are a leading pharma engineeringcompany shaping the future of API pharma engineering globally. Leveraging theexpertise of 2000 employees across Denmark India and the US we designbuild and optimise pharmaceutical manufacturing facilities that are essentialto the health and well-being of patients everywhere.
Our success isdriven by passion innovation and collaboration with our customers andacross our teams and disciplines. If you share our dedication to a noble causeand our passion for API pharma engineering then NNE is the place for you.

About the role
As our new SeniorQuality Engineer Computer System Validation you will independently lead anddeliver complex validation solutions of moderate size across pharmaceuticalmanufacturing IT projects. You will provide quality and validation leadershipfrom requirements and design through testing installation handover andproject close-out while balancing compliance risk delivery timelines andoperational usability. Acting as a subject matter expert you will strengthenproject execution coach colleagues and contribute to the continuousimprovement of NNE validation processes and strategic initiatives.

Location: Bangalore India
Experience: 6-8 years
Department Manufacturing IT Computer System Validation

How you mightspend your days
As our new Senior Quality Engineer Computer System Validation you will:

• Lead CSV/OV strategy validation planning and execution activities.
• Guide teams in protocol test plan and validation deliverable preparation review and execution.
• Support FAT SAT UAT IQ/OQ/PQ defect management deviation handling and TIMS activities.
• Ensure compliance with NNE QMS and regulatory requirements across projects.
• Conduct and participate in risk assessments and quality reviews.
• Review requirements design specifications test documentation and validation reports.
• Coordinate validation activities across IT OT Automation Engineering and Quality teams.
• Oversee supplier deliverables including SIR/SIP reviews. (if needed)
• Support project planning estimation progress tracking issue resolution and customer interactions.
• Drive continuous improvement initiatives training programs and department process development.
• Support SER/SAR preparation and ensure successful project handover and documentation closeout.

Who you are
We care about whoyou are as a the end how you work and your energy is what impactsthe effort we do as a team. As a person you:

• Thrive in a collaborative and multicultural environment and enjoy working with colleagues customers and project stakeholders.
• Are structured detail-oriented and committed to delivering high-quality work in regulated project environments.
• Take ownership of your tasks and follow through with a strong sense of accountability.
• Communicate clearly and effectively with both technical and non-technical stakeholders.
• Are curious and eager to learn new validation methodologies regulatory requirements quality standards and industry best practices within regulated manufacturing environments.
• Have a quality mindset and understand the importance of compliance documentation and data integrity.
• Are proactive in identifying risks issues and improvement opportunities during project execution.
• Enjoy working as part of a team and supporting others through knowledge sharing and collaboration.
• Stay positive and solution-oriented when working in complex project environments.

What you bring to the role
In all positionsthere are some things that are needed and others a bonus. We believe thesequalifications are needed for you to do well in this role:

• Bachelors or masters degree in engineering Computer Science Information Technology Life Sciences Pharmacy Automation or a related discipline.
• Minimum 6-8 years of experience in Computer System Validation (CSV) Operational Verification (OV) Qualification or Quality Assurance within pharmaceutical biotechnology medical devices or other regulated industries.
• Strong experience in planning reviewing and executing validation deliverables including Validation Plans Risk Assessments Traceability Matrices FAT SAT UAT IQ OQ PQ and Validation Summary Reports.
• Proven experience in leading validation and quality review activities ensuring compliance with project requirements corporate quality standards and regulatory expectations.
• Sound knowledge of GMP GEP GAMP 5 Data Integrity Annex 11 21 CFR Part 11 ALCOA principles and Computerized System Validation methodologies.
• Experience in developing and reviewing Operational Verification (OV) strategies and validation approaches using risk-based methodologies.
• Demonstrated expertise in requirements review design review test specification review defect management deviation handling change control and CAPA processes.
• Experience working with Test Management Information Systems (TIMS) or equivalent tools for validation and testing activities.
• Ability to conduct and facilitate risk assessments identify compliance gaps and drive mitigation actions throughout the project lifecycle.
• Experience coordinating with cross-functional teams including Quality Assurance Automation IT/OT Engineering Process Manufacturing and Project Management.
• Knowledge of supplier quality management activities including review and oversight of Supplier Information Requirements (SIR) Supplier Information Packages (SIP) and vendor documentation.
• Experience supporting audits inspections validation assessments and ensuring projects remain audit ready.
• Strong understanding of system lifecycle management documentation governance validation traceability and handover processes.
• Excellent analytical problem-solving stakeholder management communication and leadership skills.
• Ability to mentor and guide validation teams provide GMP/GEP training and support continuous improvement initiatives.
• Ability to work independently while leading quality and validation activities across multiple projects and disciplines.

Life at NNE.
NNE is short for Novo NordiskEngineering. And for all of us who work here NNE means so much more.
At NNE you become part of a vibrantproject-based environment built on close day-to-day collaboration. The role istherefore primarily on-site with physical presence at the workplace expectedfive days a week. Limited flexibility for occasional remote work may beaccommodated in line with business needs.
We are at our core a people businessand as such committed to continuously developing our people and the way wework together. We do not expect you to know it all from day one and we trulybelieve a great start makes a real difference. We therefore welcome newcolleagues with our award-nominated onboarding programme supported by a rangeof in-house talent and development initiatives designed to support yourlong-term growth.

Did we spark your curiosity If youreready to join our passion lets hear from you.

Deadline ofapplication is e.g. Sep 30 2026
Questions beforeapplyingPlease contact

Please note:

We only accept applications submitted through our online recruitment system

You do not need to attach a cover letter but please include a few sentences about why you are applying in your resume or CV

We invite to interviews on a running basis.

Fair hiring: At NNE we are committed to an inclusive recruitmentprocess and equal opportunities for all job applicants. To maintain fairnesswe request that you refrain from including a personal photo in your CV.

Still searchingfor the right opportunity
If this position isnt quite what yourelooking for but you know someone who would excel in this role please sharethis job post. And dont forget to explore our other exciting opportunities your future role at NNE might be just around the corner! Visit our Career Site

Required Experience:

Senior IC