Senior AIT Quality Engineer

NNE Inc.; Hinoba-an; On-site; PHP 995,000 - 1,393,000; Full time

Job summary

NNE is seeking a Senior Quality Engineer – Computer System Validation to independently lead complex validation solutions across pharmaceutical manufacturing IT projects. You will provide quality leadership from requirements through testing, installation, handover, and close-out, balancing compliance risk, timelines, and usability.

Location: Bangalore, India. Experience: 6–8 years in CSV/QA within regulated industries.

Qualifications

• Bachelor’s or master’s degree in engineering, computer science, life sciences, pharmacy or related discipline.
• Minimum 6–8 years in CSV, OV, qualification or QA within regulated industries.
• Proven experience in leading validation and quality review activities per regulatory expectations.
• Strong knowledge of GMP, 21 CFR Part 11 and data integrity principles.

Responsibilities

• Lead CSV/OV strategy, validation planning, and execution activities.
• Guide teams in protocol, test plan, and validation deliverable preparation and execution.
• Support FAT, SAT, UAT, IQ/OQ/PQ, defect management, deviation handling, and TIMS activities.
• Ensure compliance with GMP, GEP, GAMP 5 and regulatory requirements across projects.
• Conduct and participate in risk assessments and quality reviews.
• Review requirements, design specs, test docs, and validation reports.
• Coordinate validation activities across IT, OT, Automation, Engineering and Quality teams.
• Oversee supplier deliverables, including SIR/SIP reviews where needed.
• Support project planning, estimation, progress tracking, issue resolution and customer interactions.
• Drive continuous improvement initiatives and department process development.
• Support SER/SAR preparation and ensure successful project handover and closeout.

Skills

CSV Strategy

Regulatory Knowledge

Risk Assessment

Cross-functional Leadership

Documentation Governance

Communication

Mentoring

Education

Bachelor’s or Master’s degree in Engineering/related field

Tools

TIMS

GAMP 5

Audit/QA Tools

SIR/SIP Review

Job description

SeniorAIT Quality Engineer

Who we are

We are a leading pharma engineeringcompany shaping the future of API pharma engineering globally. Leveraging theexpertise of 2,000+ employees across Denmark, India, and the US, we design,build 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 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

We care about whoyou are as a person. In the end, how you work, and your energy is what impacts the 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 positions there are some things that are needed, and others a bonus. We believe these qualifications are needed for you to do well in this 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.

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