Qualification Engineer (OT Systems)

Position Overview
The Qualification Engineer is responsible for ensuring that Operational Technology (OT) systems are qualified and validated in compliance with Novartis Quality Management requirements and applicable regulatory standards. The role supports project delivery by leading qualification activities, ensuring quality oversight, and coordinating validation deliverables throughout the project lifecycle.

The successful candidate will act as the primary quality representative for qualification and testing activities, working closely with project teams, Quality Assurance, suppliers, and stakeholders to ensure that all validation and qualification activities meet internal and regulatory expectations.

Key ResponsibilitiesValidation \& Qualification Management* Ensure qualification and validation activities for OT systems are executed in accordance with the Novartis Quality Manual, corporate procedures, and applicable GMP regulations.

• Author, review, and approve qualification and validation documentation including:


• + Validation Plans

+ User Requirement Specifications (URS)
+ Functional Specifications (FS)
+ Risk Assessments
+ Installation Qualification (IQ)
+ Operational Qualification (OQ)
+ Performance Qualification (PQ)
+ Traceability Matrices
+ Validation Summary Reports

Quality Oversight* Review and approve qualification deliverables provided by system vendors and suppliers.

• Verify compliance of supplier documentation with Novartis quality standards and regulatory requirements.


• Act as the project quality representative for qualification and testing activities.


• Liaise with local Site Quality Assurance (QA) and QA eCompliance teams as required.

Project Leadership* Lead and coordinate project test resources supporting qualification activities.

• Monitor qualification progress and provide status updates to project stakeholders.


• Identify quality risks and implement mitigation strategies.

Supplier Management* Provide guidance and support to suppliers regarding qualification and validation expectations.

• Review supplier testing approaches and documentation to ensure alignment with Novartis standards.


• Support supplier audits and quality assessments where required.

Compliance \& Documentation* Ensure all qualification documentation is complete, accurate, and audit\-ready.

• Support regulatory inspections and internal audits.


• Maintain compliance with GMP, GAMP5, Data Integrity, and CSV requirements.

Requirements

Required Qualifications* Bachelor’s or Master’s degree in Engineering, Automation, Life Sciences, Computer Science, or a related technical discipline.

• Minimum 5 years of experience in qualification, validation, automation, or quality engineering within a regulated pharmaceutical or biotech environment.


• Strong knowledge of GMP, GAMP5, CSV, Data Integrity, and regulatory requirements.


• Experience qualifying OT systems, automation platforms, SCADA, MES, or manufacturing systems.


• Strong documentation and stakeholder management skills.


• Fluent English required. German or French language skills are considered an advantage depending on location.

Preferred Experience* Experience within pharmaceutical manufacturing, radioligand therapy (RLT), biotech, or sterile production environments.

• Experience working with global project teams and external suppliers.

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