Job Summary
The ideal candidate will be responsible for overseeing the commissioning and qualification activities of facility, process, HVAC, clean room, and utility services in pharmaceutical facilities. This includes preparing protocols and reports, creating standard operating procedures, and conducting site support activities following ISPE/ASTM methodologies.
Main Accountabilities:
* Prepare and execute commissioning and qualification protocols for various systems, including facility and process/utility equipment.
* Develop and implement project plans, ensuring timely completion and compliance with regulatory guidelines.
* Conduct on-site support for commissioning and qualification activities, utilizing GDP, GEP, C&Q baseline guides, GAMP 5, and cGMP principles.
* Review and prepare validation master plans, validation plans, and validation documents.
* Execute commissioning and validation activities for clean room and HVAC systems, adhering to required standards.
* Prepare and execute pre-commissioning and commissioning checklists for various systems.
* Develop and implement FAT/SAT/IOQ protocols/reports for facility, utility, and process equipment.
Essential Requirements:
* Education: Degree in Mechanical or Chemical Engineering.
* 8-10 years of experience in the pharmaceutical, chemical, or FMCG industry.
* Deep understanding of project commissioning and qualification activities, including facility/HVAC/clean room/black and clean utility services/process equipment.
* Excellent knowledge of project management, including planning, cost management, time management, construction management, quality management, contract administration, safety management, and statutory approvals.
* Fluent in English and Spanish, written and spoken.
About Novartis
We are committed to reimagining medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company in the world.
Benefits and Rewards
We offer a range of benefits and rewards that will help you thrive personally and professionally.
Commitment to Diversity and Inclusion
We are dedicated to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.