Job Opportunity at Novartis
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Summary
Position: Commissioning & Qualification / Compliance Engineer
The engineer manages Projects Facility, Process, HVAC, Clean room, and Utility Services Commissioning & Qualifications activities, including developing protocols and executing reports for manufacturing equipment. Responsible for handling multiple projects considering end-to-end project management, organizing, budgeting, scheduling, executing, and monitoring project performance as per timelines.
Major Accountabilities
1. Preparation, execution, and compilation of Facility, Process, HVAC, Clean room, and Utility Services Commissioning & Qualifications activities protocols and reports for pharmaceutical manufacturing facilities.
2. Preparation of SOPs and work instructions.
3. Onsite support for C&Q activities following ISPE / ASTM methodologies, utilizing GDP, GEP, C&Q baseline guides, GAMP 5, and cGMP principles.
4. In-depth knowledge of regulatory guidelines such as USFDA, MHRA, WHO, ISO, 21 CFR part 11.
5. Planning, development, execution, and reporting of C&Q deliverables.
6. Preparation and review of validation master plans, validation documents, and execution of validation activities (DQ, IQ, OQ, PQ) for clean room and HVAC systems.
7. Preparation and execution of pre-commissioning and commissioning checklists for various systems.
8. Preparation and execution of FAT/SAT/IOQ protocols and reports for facility, utility, and process equipment.
9. Continuous improvement and optimization of qualification activities and SOPs.
10. Documentation management for qualification, periodic reviews, and compliance.
11. Maintaining procedures in compliance with the Quality Management System and implementing changes as required.
Essential Requirements
* 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 related to facilities, HVAC, clean rooms, utilities, and process equipment within the pharmaceutical industry.
* Knowledge of project management aspects including planning, cost, time, construction, quality, contract, safety, and statutory approvals.
* Fluent in English and Spanish, both written and spoken.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people's lives. Our vision is to become the most valued and trusted medicines company. Our people drive us each day to reach our ambitions. Join us in this mission
Additional Information
Learn more about our rewards, diversity, and inclusion initiatives, and how we support your professional and personal growth through our handbook and talent community.
#J-18808-Ljbffr