Qualification & Compliance Engineer

Job Description Summary

Job Description

Key Responsibilities

• Coordinate calibration, re-qualification, and validation activities across equipment, facilities, utilities, and systems, including management of external service providers.

• Collaborate with vendors and cross-functional teams such as Engineering, Quality, Safety, and Operations to ensure effective execution of compliance activities.

• Lead planning, execution, and coordination meetings for calibration, HVAC re-qualification, re-validation, cleanroom, and thermal validation activities.

• Oversee qualification, commissioning, calibration, HVAC validation, cleanroom validation, and maintenance tasks using a risk-based approach.

• Ensure timely closure of quality, HSE observations, deviations, corrective actions, and compliance-related tasks.

• Investigate engineering deviations, equipment failures, and system issues through root cause analysis and implementation of corrective actions.

• Ensure adherence to quality standards, procedures, regulatory requirements, safety expectations, and data integrity principles.

• Track, analyze, and report compliance KPIs to ensure activities are completed within planned timelines.

• Support audits by maintaining accurate documentation, providing required evidence, and driving timely closure of audit actions.

• Promote continuous improvement, safety culture, and data integrity culture through walkthroughs, training support, compliance monitoring, and process enhancement initiatives.

Essential Requirements

• Degree in Engineering (Bachelor’s or Master’s), preferably in Electrical or Mechanical Engineering

• Minimum two years of experience in qualification, calibration, or instrumentation within the pharmaceutical industry

• Strong knowledge of calibration and qualification methodologies for engineering systems and equipment

• Experience working with pharmaceutical or chemical manufacturing equipment and processes

• Solid understanding of root cause analysis techniques and quality frameworks, including document control practices

• Knowledge of Good Manufacturing Practice and health, safety, and environmental standards, with fluent English communication skills

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Novartis is a proud member of the ILO Global Business and Disability Network and the Valuable 500, promoting the inclusion of people with disabilities in workplaces around the world. We also collaborate with international partners, such as Disability: IN, Purple Space, and Business Disability Forum to identify and develop best practice solutions to enable people with disabilities to participate as equal members of our organization.

Skills Desired