Process Engineer- PAT

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because 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.

Job Summary

Role Summary

The Process Engineer – PAT will lead and support the design, deployment, and lifecycle management of PAT solutions across peptide, oligonucleotide, and small-molecule drug product manufacturing platforms, with a special focus on organic synthesis, crystallization, and formulation operations. The role bridges process science, advanced analytics, and digital control systems to enable real-time process understanding and predictive control in alignment with Quality by Design (QbD), ICH Q8–Q14, and digital twin frameworks.

Key Responsibilities

1. PAT Strategy & Implementation

• Identify and implement suitable PAT tools end to end in the R&D developmental workflow (Drug substance to Drug product) and transfer critical PAT tools to the manufacturing plant at a commercial scale.
• Develop calibration and chemometric models (PLS, PCA, ANN) for real-time release or feedback control.
• Collaborate with the automation team to integrate PAT tools with automation platforms (DeltaV, Siemens PCS7, SynTQ, SIPAT, Seeq) for model-based control.

2. Process Understanding & Scale up

• Collaborate with process engineers/scientists, support development of process models for synthesis, crystallization, and formulation and enable robust scale-up.
• Use PAT data for DoE-based optimization, multivariate analysis (MVDA), and robustness assessment.
• Support continuous-manufacturing and intensification initiatives through inline analytics.

3. Data Analytics & Systems Integration

• Develop data pipelines linking PAT instruments with historians, MES, and data-lakes.
• Apply advanced analytics (Python, MATLAB, SIMCA, Unscrambler, JMP) for trend prediction and fault detection.
• Collaborate with data-science teams for AI/ML model development for yield, impurity, and polymorph prediction.

4. Compliance & Lifecycle Management

• Ensure regulatory alignment with ICH Q8–Q11, FDA/EMA PAT frameworks.
• Prepare validation protocols, SOPs, and regulatory documentation for PAT method qualification.
• Manage change control, deviation, and audit responses related to PAT systems.

5. Cross-Functional Collaboration

• Partner with R&D, MSAT, Automation, QA/QC, and Manufacturing for PAT-enabled process transfers.
• Support tech transfer, scale-up, and troubleshooting of operations.
• Collaborate with external vendors, academics, and technology providers.

Qualifications

Education: B.E./B.Tech/M.Tech/M.S. in Chemical Engineering, Biotechnology, or Pharmaceutical Engineering.

Experience: 3-6 years in process development or manufacturing within peptide, oligonucleotide, or small-molecule environments, with proven record of accomplishment in PAT and chemometrics implementation.

Technical Competencies

• Deep understanding of reaction, crystallization, solid-state transitions, and peptide purification processes, familiarity with drug product processes (oral solid dosage & parenteral will be plus)  • Hands-on experience with inline/online/atline spectroscopic, scattering & microscopic techniques (Raman, NIR, FTIR, MS, FBRM, PVM, NMR). Familiarity with chromatographic and mass spectrometry based tools will be plus.
• Familiarity with MVDA, digital twins, and process-control strategies.
• Understanding of GMP validation, lifecycle management, and regulatory PAT expectations.

Behavioral Competencies

• Innovative and data-driven mindset with passion for process analytics and digital transformation.
• Excellent problem-solving, communication, and documentation skills.
• Ability to manage multiple projects simultaneously and collaborate seamlessly across R&D and plant.

Preferred Certifications / Tools

• Lean Six Sigma, QbD, or Data Analytics certifications.
• Experience with SIMCA, Unscrambler, MATLAB, Python, Seeq, or SynTQ/SIPAT.
• Knowledge of cGMP, 21 CFR Part 11, and data integrity principles.

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered
At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
For more details, please visit our career website at https://careers.drreddys.com/#!/