C&Q Engineer - Senior Executive

As a C&Q Engineer - Senior Executive at Novartis Healthcare Private Limited in Hyderabad, you will be responsible for managing Projects Facility, Process, HVAC, Clean room, and Utility Services Commissioning & Qualifications activities for Pharmaceutical OSD/Injectable/API/Oncology/Biotechnology/Vaccine manufacturing facilities. Your role involves developing Protocols, executing reports, organizing, budgeting, scheduling, and monitoring project performance within required timelines. **Key Responsibilities:** - Prepare, execute, and compile Facility, Process, HVAC, Clean room, and Utility Services Commissioning & Qualifications activities Protocols/reports for Pharmaceutical facilities - Provide onsite support for C&Q activities following ISPE/ASTM methodologies and regulatory guidelines - Plan, develop, execute, and report C&Q Deliverables - Coordinate with package design engineers, clients, and project managers for effective leveraging and timely document preparations - Demonstrate in-depth knowledge of Regulatory Guidelines like USFDA, MHRA, WHO, ISO, 21 CFR part 11, and other regulatory guidelines - Prepare and review Validation master plan, Validation documents, Commissioning & Validation execution of Clean Room & HVAC Systems - Execute Pre-commissioning & Commissioning checklists for various systems including Facility & Process/Utility Equipments - Perform Facility, Utility & process equipment FAT/SAT Protocols/Reports **Qualifications Required:** - Degree in Mechanical/Chemical Engineering with 10-12 years of experience in Pharmaceutical/Chemical/FMCG Industry - Deep understanding of Project Commissioning & Qualification activities within pharmaceutical OSD/Injectable/API/Oncology/Biotechnology - Good knowledge of Project management including Project planning, Cost Management, Time Management, Construction management, Quality Management, Contract Administration, Safety Management & Statutory approvals management As a C&Q Engineer - Senior Executive at Novartis Healthcare Private Limited in Hyderabad, you will be responsible for managing Projects Facility, Process, HVAC, Clean room, and Utility Services Commissioning & Qualifications activities for Pharmaceutical OSD/Injectable/API/Oncology/Biotechnology/Vaccine manufacturing facilities. Your role involves developing Protocols, executing reports, organizing, budgeting, scheduling, and monitoring project performance within required timelines. **Key Responsibilities:** - Prepare, execute, and compile Facility, Process, HVAC, Clean room, and Utility Services Commissioning & Qualifications activities Protocols/reports for Pharmaceutical facilities - Provide onsite support for C&Q activities following ISPE/ASTM methodologies and regulatory guidelines - Plan, develop, execute, and report C&Q Deliverables - Coordinate with package design engineers, clients, and project managers for effective leveraging and timely document preparations - Demonstrate in-depth knowledge of Regulatory Guidelines like USFDA, MHRA, WHO, ISO, 21 CFR part 11, and other regulatory guidelines - Prepare and review Validation master plan, Validation documents, Commissioning & Validation execution of Clean Room & HVAC Systems - Execute Pre-commissioning & Commissioning checklists for various systems including Facility & Process/Utility Equipments - Perform Facility, Utility & process equipment FAT/SAT Protocols/Reports **Qualifications Required:** - Degree in Mechanical/Chemical Engineering with 10-12 years of experience in Pharmaceutical/Chemical/FMCG Industry - Deep understanding of Project Commissioning & Qualification activities within pharmaceutical OSD/Injectable/API/Oncology/Biotechnology - Good knowledge of Project management including Project planning, Cost Management, Time Management, Construction management, Quality Management, Contract Administration, Safety Management & Statutory approvals management