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Junior validation and process engineer - sostituzione maternità

Peschiera
CEDIC
Pubblicato il 2 maggio
Descrizione

About the Company

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At Cedic we offer solutions for living. Our diverse product portfolio, specialising in fluid delivery, is designed with the main objective of improving the patient’s quality of life. That is why we continually invest in our people and facilities to remain at the forefront of innovation and responsive to market needs.

Main purpose of the job
The Junior Validation & Process Engineer’s mission is to ensure that manufacturing processes comply with regulatory standards, business requirements and operational efficiency targets. The Junior Validation & Process Engineer executes validation activities and contributes to the development, optimization and continuous improvement of manufacturing processes from Design & Development collaboration through industrialization and post-launch activities.
You will report directly to the Validation Manager.

Main responsibilities and duties
Support the definition of validation strategies with Project Managers, ensuring alignment with requirements, timelines and budget
Execute validation activities and prepare the documentation (VP, IQ, OQ, PQ, VR) under supervision
Support validation test activities performed by the validation laboratory and ensure proper documentation and traceability
Contribute to the industrialization of new products by supporting process development and optimization in collaboration with Engineering, Manufacturing and Quality departments
Participate in Process Risk Analysis with cross-functional teams including Regulatory, Engineering, Manufacturing and Quality
Collect and analyze manufacturing data to support process improvements and performance monitoring
Support investigation of non-conformities, perform root cause analysis with guidance and contribute to corrective and preventive actions
Assist manufacturing teams in troubleshooting process deviations and technical issues.
Participate in validation and process improvement initiatives and contribute to the implementation of new methods and tools
Support internal and external audits and contribute to validation and process compliance activities.

Key Competencies / Qualifications /Skills
Bachelor’s or master’s degree in engineering or related field.
0–3 years of experience in validation, manufacturing or process engineering
Basic knowledge of validation principles (IQ, OQ, PQ) and interest in regulated environments (e.g. medical devices, pharma)
Basic understanding of manufacturing processes (assembly, packaging or similar)
Familiarity with data analysis and statistics (e.g. DOE concepts, capability analysis)
Basic knowledge of statistical software such as Minitab or equivalent is a plus
Good organizational skills and ability to manage tasks with guidance
Analytical mindset and problem-solving attitude
Willingness to learn and grow in a cross-functional environment. xjrgpwk
Good communication skills and ability to work in a team
Advanced written and spoken English and Italian.

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