Process Engineering Specialist

Job Summary

• You will be responsible for development and Scale-up of processes for new products, Technology Transfer & Process Validation of the product at plant scale.
• You will be responsible to work in collaboration with Chemistry team & provide necessary inputs during Design of Experiments (DoE) studies & further process optimization.
• You will be responsible to develop detailed process understanding & ensure scale-up feasibility using fundamental studies of reaction kinetics, Crystallization, Process Safety, Process analytical technology (PAT).
• You will be responsible to ensure appropriate facility/equipment/technology mapping at in house/SBP plants.
• You will be responsible to draft the process for scale up i.e Kilo lab, Critical Process Parameter (CPP) and validation batches in co-ordination with Cross Functional Teams.
• You will be responsible for Technology Transfer & Scale-up of Active Pharmaceutical Ingredient (API) and engineering optimization studies with minimal guidance 
• You will be responsible for supporting Drug Master Filing (DMF), address regulatory queries related to process engineering, and demonstrate awareness of process validation, GMP, and GLP aspects to facilitate smooth regulatory filing.
• Your role will involve staying familiar with the Intellectual property (IP) landscape and relevant literature, participate in industry forums, and disseminate knowledge within PE teams, applying existing knowledge and technologies during development.
• You will be responsible for proactive planning & timely completion of Process Engineering tasks in alignment with project goals.
• You will be working collaboratively in cross functional team to drive Process Engineering activities.
• You will be responsible to Provide technical & execution guidance to new members in Process Engineering team. 

Educational qualification:

• Have work experience on Process scale up of Active Pharmaceutical Ingredients.
• Knowledge of core chemical engineering like Heat & mass transfer, reaction engineering, fluid dynamics, separation technologies etc. for process optimization & scale up 
• Experience in Operational Excellence, Scale-up process.
• Knowledge of product Development, basic understanding of Chemistry, analytical, RA and IP 
• Experience in Technology Transfer
• Should be well versed with Current Good Manufacturing Practice (CGMP) practices & quality systems in Pharma industry  
• Familiarity with tools for engineering optimization like Design of Engineering (DoE), dynochem.

Behavioral Skills

• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving abilities.
• Ability to work collaboratively with own team and cross-functional teams. 

About the Department

Integrated Product Development Organisation

Benefits Offered