C&Q Engineer - Executive

Novartis

5 - 8 years

Hyderabad

Posted: 22/06/2025

Job Description

Summary

-EngineerExecute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost effective technical solutions, ensuring technical quality to enable the overall site / project objectives.Maintenance Technician IIResponsible for execution of maintenance And calibration activities and commissioning activities for projects at site level.Process Engineer Supervise plant engineering team providing technical assistance to the function and ensuring that the best possible maintenance, repair and/or modifications are undergoneOther positions Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality withintechnical area of responsibility.

About the Role

Key Responsibilities:

Responsible for Preparation/execution/compiling of Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities Protocols/reports for the Pharmaceutical facilities which includes OSD/Injectable/API/Oncology/Biotechnology /Vaccine manufacturing facilities.
Responsible for onsite support C&Q activities by following ISPE/ASTM methodologies utilizing GDP, GEP, C&Q Base line guides, GAMP 5 & cGMP Principles.
Planning, developing, execution, reporting of C&Q Deliverables.
Coordination with different package design engineers & Clients, Project managers to enable effective leveraging and timely Right First Time Documents preparations, execution and compliance of Commissioning & Qualification deliverables
In depth knowledge of Regulatory Guidelines- USFDA, MHRA, WHO, ISO, 21 CFR part 11 & other regulatory guidelines
Preparations of Commissioning & Qualifications Protocols/ Standard operating Procedures/ Work instructions
as applicable
Prepare/ Review of Validation master plan, Validation plans, Validation Documents, Commissioning & Validation execution of Clean Room & HVAC Systems (Such as DQ, IQ, OQ & PQ) in Pharmaceutical Industries as per the required standards
Preparation and review of qualification protocols, Temperature mapping protocols, Layouts and SOPs as per established procedures.
Preparations & execution of Pre-commissioning & Commissioning checklists for various systems including Facility & Process/Utility Equipments
Preparation & execution of Facility, Utility & process equipment FAT/SAT Protocols/Reports

Essential Requirements:

Degree in Mechanical/Chemical Engineering with 5-8 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 pharmaceutical OSD/Injectable/API/Oncology/Biotechnology
Good Knowledge of Project management like - Project planning, Cost Management, Time Management, Construction management, Quality Management, Contract Administration, Safety Management & required Statutory approvals management.

Desirable Requirements:

Degree in Mechanical/Chemical Engineering or equivalent.
Fluent in English and proficient in local language.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

About Company

Novartis is a leading global healthcare company headquartered in Basel, Switzerland. It specializes in the research, development, manufacturing, and marketing of innovative pharmaceuticals. Formed in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis focuses on areas such as oncology, neuroscience, immunology, cardiovascular diseases, and gene therapies.With a strong commitment to scientific innovation, Novartis invests heavily in R&D and collaborates with biotech companies and academic institutions worldwide. The company operates in over 140 countries and serves millions of patients globally. Novartis is also known for its efforts in access to medicine, using programs like Novartis Access and Novartis Foundation to support underserved populations.