Process Engineer

We are seeking a dynamic and experienced Process Engineer in Active Pharmaceutical Ingredient (API) development with proven expertise in scaling up or down technologies to meet production demands. Proficient in Process and Chemical Engineering, adept at troubleshooting complex projects, facilitating technology transfer, and optimizing operations.

Roles & Responsibilities

• You will beresponsible to use process modelling tools like Dyno Chem , VISMIX for reaction, crystallization, filtration, solubility and mixing studies.
• You will beresponsible to generate and interpret PAT data to provide process understanding related to unit operation, Develop qualitative models to monitor CPP and CQAs.
• You will be responsible to provide scale up recommendation/control strategy based on PAT data and should develop detailed process understanding & ensure scale-up feasibility using fundamental studies of reaction kinetics, Crystallization, Process Safety, PAT & process simulation studies.
• You will beresponsible to execute lab batches / Kilo lab/CPP batches to verify design space at scale and share observations for fine tuning of process, review data sheets, scale up guideline document and conduct basic scale up calculations.
• You will be responsible to execute trial and validation batches and support in related activities at plant in the time of scale up.
• You will beresponsible to Investigate and troubleshoot in case of issues in scale up/validation and support troubleshooting activitiesin case of issues in scale up/validation batches.
• You will be responsible to document executed experiments as per quality requirement and create online documents for execution of all batches and highlight/update the critical observations during batch process.
• 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 to Evaluate and establish possibilities of solvent, reagents and product recoveries.
• You will be responsible to execute kilo lab batches for scale up studies, material build up customer sample seeding. Also, support and review in compilation of the Kilo lab reports (process Parameters, observations, and compliance) on completed batches.
• You will Prepare campaign/equipment plan with minimal guidance and understand risks/hazards associated in the process and powder handling operations.
• You will be responsible to prepare manufacturing process and process engineering documents with minimal guidance.
• You will be responsible for generation of technical data/conclusion through usage of MixIT simulation and Dynochem software.- Contribute in lab safety initiatives.
• You should have basic understanding ofrisks involved in process and powder handling operations (RC1/DSC/TSU/ARC/MIE)..

Qualifications

Educational qualification:

Minimum work experience:

Skills & attributes:

Technical Skills

• Have work experience on Process scale up of Active Pharmaceutical Ingredients.
• Experience in Process Optimization (Manufacturing)
• Experience in Process Intensification
• Experience in Operational Excellence
• Experience in Chemical Process Engineering
• Experience in Technology Transfer

Behavioural Skills

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