Senior AIT Quality Engineer

NNE; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

NNE in Bangalore, India seeks a Senior Quality Engineer - Computer System Validation to lead complex CSV/OV validation across pharmaceutical manufacturing IT projects. You will provide quality leadership from requirements through handover, ensuring compliance with GMP, GEP, GAMP 5, and data integrity while guiding teams and driving improvements.

Role emphasizes on-site collaboration within Manufacturing IT - CSV, with opportunities to mentor peers, contribute to risk assessments, and support

Qualifications

• Bachelor’s or Master’s degree in Engineering/IT/Life Sciences; regulatory exposure preferred.
• Experience in CSV, OV, QA within regulated industries is essential.

Responsibilities

• Lead CSV/OV strategy, validation planning, and execution across projects.
• Review requirements, design, test documentation, and validation reports; ensure GMP/GEP compliance.

Skills

CSV

Quality Assurance

Risk Assessments

Regulatory Compliance

GAMP 5

TIMS

Documentation Governance

Leadership

Education

Bachelor’s or Master’s degree in Engineering/IT/Life Sciences

Tools

TIMS

Job description

Who We Are

We are a leading pharma engineering company shaping the future of API pharma engineering globally. Leveraging the expertise of 2,000+ employees across Denmark, India, and the US, we design, build and optimise pharmaceutical manufacturing facilities that are essential to the health and well-being of patients everywhere. Our success is driven by passion, innovation, and collaboration - with our customers and across our teams and disciplines. If you share our dedication to a noble cause and our passion for API pharma engineering, then NNE is the place for you.

About The Role

As our new Senior Quality Engineer - Computer System Validation, you will independently lead and deliver complex validation solutions of moderate size across pharmaceutical manufacturing IT projects. You will provide quality and validation leadership from requirements and design through testing, installation, handover, and project close-out, while balancing compliance risk, delivery timelines, and operational usability. Acting as a subject matter expert, you will strengthen project execution, coach colleagues, and contribute to the continuous improvement of NNE validation processes and strategic initiatives.

Location: Bangalore, India

Experience: 6-8 years

Department Manufacturing IT - Computer System Validation

How You Might Spend Your Days

• 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

• 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

• Bachelor’s or master’s 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 Nordisk Engineering. And for all of us who work here, NNE means so much more. At NNE, you become part of a vibrant, project-based environment built on close day-to-day collaboration. The role is therefore primarily on-site, with physical presence at the workplace expected five days a week. Limited flexibility for occasional remote work may be accommodated in line with business needs.

We are, at our core, a people business and, as such, committed to continuously developing our people and the way we work together. We do not expect you to know it all from day one, and we truly believe a great start makes a real difference. We therefore welcome new colleagues with our award-nominated onboarding programme, supported by a range of in-house talent and development initiatives designed to support your long-term growth.

Deadline of application is - e.g. Sep 30, 2026

At NNE, we are committed to an inclusive recruitment process and equal opportunities for all job applicants. To maintain fairness, we request that you refrain from including a personal photo in your CV.