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Commissioning and Qualification Specialist
hace 2 meses
About the Role
Novartis Farmacéutica is seeking a highly skilled Commissioning and Qualification Specialist to join our team in Mexico. As a key member of our Engineering department, you will be responsible for planning, implementing, and reporting on the execution of commissioning and qualification of equipment for pharmaceutical production and drug testing in quality control (QC) Lab.
Key Responsibilities:
- Execute commissioning and qualification activities based on expertise and GMP regulations for equipment in pharmaceutical production and drug testing.
- Identify, understand, and define technical solutions for equipment.
- Develop commissioning and qualification plans together with other stakeholders within Novartis (users, quality).
- Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
- Develop and implement DQ, IQ, and OQ protocols, in cooperation with equipment suppliers.
- Responsibility for personal professional development, gaining experience, and competences.
- Implementing and following instructions and requirements to ensure safe working, protection of assets, and the environment.
Requirements:
- Degree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent.
- Minimum 1 year of experience in engineering and/or production environment.
- Fluent in English and proficient in local language.
- Knowledge of Microsoft Office.
About Novartis
Our purpose is to reimagine medicine to improve and extend people's lives. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
