Team Leader - Process Engineering

Good Health Can’t Wait

We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.

For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets).

‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency

Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

1. Lead process engineering activities in the plant, including the critical mapping of suitable equipment for scale-up trials, validation, and commercial scale-up manufacturing.
2. Provide essential MSAT support to manufacturing operations to ensure the achievement of monthly production targets.
3. Rigorously review and coordinate the change management process, including the preparation of PFD, P&ID, and technical justifications for equipment modifications, batch size alterations, and facility enhancements. Conduct thorough risk assessments for changes in batch size and facility using Quality risk assessment tools.
4. Ensure strict adherence to the safety and cGMP quality standards during the execution of all scale-up batches.
5. Actively engage in periodic manufacturing reviews to guarantee compliance, productivity, and timely deliverables.
6. Foster and maintain robust collaboration and partnerships with cross-functional teams to drive valuable business outcomes.
7. Ensure that investigations pertaining to market complaints, OOS/OOT, and incidents are conducted meticulously as per respective SOPs, employing rigorous Root Cause analysis and producing comprehensive investigation reports.
8. Enforce the completion of investigations within committed timelines and ensure the closure of reports with appropriate CAPA and its effective implementation.
9. Conduct thorough trending and analysis of quality and operational parameter data for investigations and continuous process improvements to achieve process robustness.
10. Collaborate strategically with the Operational excellence team to achieve targeted savings.
11. Spearhead and implement continuous improvement activities to increase productivity, improve solvent recoveries, enhance efficiency, and reduce costs for commercial products.
12. Conduct critical debottlenecking of equipment and product mapping to maximize facility utilisation.
13. Meticulously review performance qualification protocols and reports. Coordinate the execution of trial and validation batches for all modified and new processes.
14. Ensure the effective implementation of DCS (Distributed Control System) in work areas. Oversee required modification works in coordination with Projects, Engineering, and Production Departments.
15. Conduct comprehensive reviews of new facility creation and modifications to existing facilities for new and commercial products.
16. Develop and deliver rigorous training programmes for operating personnel, covering critical raw material handling SOPs, Critical Process Parameters, and Operational safety.
17. Prepare and review Process Safety Information with utmost diligence. Conduct thorough Process Hazard analysis and Prestart-up safety reviews (PSSR). Ensure timely upload of PHA recommendations to the portal.
18. Diligently complete assigned training for new and revised SOPs and attend mandatory training sessions for process and safety changes.
    

Qualifications

• B.Tech in Chemical Engineering with 12-15 years of experience in API industry, specifically in Process Engineering, Technical Services, or Tech Transfer
• In-depth knowledge of cGMP standards and quality management systems in pharmaceutical manufacturing
• Experience with process scale-up, validation and commercial manufacturing in API production
• Strong communication and interpersonal skills for cross-functional collaboration
  

Additional Information

About the Department

Integrated Product Development Organisation

Benefits Offered