Process Engineer- PAT

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 Q8Q14 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 Q8Q11 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 :

Qualifications

Education: B.E./ 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.

Additional Information :

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 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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

Remote Work :

No

Employment Type :

Full-time