Commissioning & Qualification / Compliance Engineer
Job ID: REQ-10044617
Date: Mar 21, 2025
Location: Spain
Summary
The Commissioning & Qualification / Compliance Engineer manages the Projects Facility, Process, HVAC, Clean room, and Utility Services Commissioning & Qualifications activities. This includes developing protocols and executing reports for manufacturing equipment. Responsible for handling multiple projects' Commissioning & Qualifications activities considering end-to-end project management. Will also be responsible for organizing, budgeting, scheduling, executing, and monitoring the performance of projects as per required timelines.
About the Role
Major Accountabilities
* Preparation, execution, and compilation of Facility, Process, HVAC, Clean room, and Utility Services Commissioning & Qualifications activities protocols/reports for pharmaceutical facilities.
* Onsite support for C&Q activities by following ISPE/ASTM methodologies utilizing GDP, GEP, C&Q baseline guides, GAMP 5, and cGMP principles. In-depth knowledge of regulatory guidelines - USFDA, MHRA, WHO, ISO, 21 CFR part 11, and other regulatory guidelines.
* Planning, developing, executing, and reporting of C&Q deliverables.
* Preparation and review of Validation Master Plan, Validation Plans, Validation Documents, and Commissioning & Validation execution of Clean Room & HVAC Systems (such as DQ, IQ, OQ & PQ) in pharmaceutical industries as per the required standards.
* Preparation and execution of Pre-commissioning & Commissioning checklists for various systems including Facility & Process/Utility Equipment.
* Preparation and execution of Facility, Utility & process equipment FAT/SAT/IOQ Protocols/Reports.
* Improve and optimize qualification activities, including modifying SOPs where required. Document periodic reviews for manufacturing equipment and utilities required onsite.
* Maintain documentation package for qualification and periodic reviews on time in compliance.
* Maintain procedures in compliance for the Engineering department. Introduce and implement change when required following the Quality Management System from Novartis.
* Education: Degree in Mechanical/Chemical Engineering.
* 8-10 years of experience in Pharmaceutical/Chemical/FMCG Industry.
* Deep understanding of Project Commissioning & Qualification activities like Facility/HVAC/Clean room/Black & Clean Utility services/Process equipment within the pharmaceutical industry.
* Good knowledge of Project management including Project planning, Cost Management, Time Management, Construction management, Quality Management, Contract Administration, Safety Management, and required Statutory approvals management.
* Fluent in English and Spanish, written and spoken.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
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Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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