Qualification Engineer (OT Systems)
Resumo da vaga pela JobGrid
Qualification Engineer (OT Systems) at Avacone: Huningue, França; Presencial; Tempo inteiro; Engenharia, manufatura e construção. JobGrid adds normalized role facts, source context, and a path to the employer application page so candidates can compare the listing before applying.
- Location and workplace: Huningue, França, Presencial
- Role classification: Engenharia, manufatura e construção, Tempo inteiro
- Source freshness: checked by JobGrid on 2026-06-09.
- Application path: candidates continue to the employer application page with non-personal referral tags.
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 Responsibilities
Validation & 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.