
Senior Process Engineer
6 days ago
We are seeking a highly skilled Process Engineering professional to join our team for Active Pharmaceutical Ingredient (API) development.
Key responsibilities include:
- Scaling up or down technologies to meet production demands using process modeling tools like Dyno Chem, VISMIX.
- Generating and interpreting PAT data to provide process understanding related to unit operation and develop qualitative models to monitor CPP and CQAs.
- Providing scale up recommendations and control strategies based on PAT data and developing detailed process understanding & ensuring scale-up feasibility using fundamental studies of reaction kinetics, Crystallization, Process Safety, PAT & process simulation studies.
- Executing lab batches / Kilo lab/CPP batches to verify design space at scale and sharing observations for fine tuning of process, reviewing data sheets, scale up guideline document and conducting basic scale up calculations.
- Executing trial and validation batches and supporting related activities at plant in the time of scale up.
- Investigating and troubleshooting in case of issues in scale up/validation and supporting troubleshooting activities in case of issues in scale up/validation batches.
- Documenting executed experiments as per quality requirement and creating online documents for execution of all batches and highlighting/update the critical observations during batch process.
- Drafting the process for scale up i.e Kilo lab, Critical Process Parameter (CPP) and validation batches in co-ordination with Cross Functional Teams.
- Evaluating and establishing possibilities of solvent, reagents and product recoveries.
- Executing kilo lab batches for scale up studies, material build up customer sample seeding. Also, supporting and reviewing in compilation of the Kilo lab reports (process Parameters, observations, and compliance) on completed batches.
- Preparing campaign/equipment plan with minimal guidance and understanding risks/hazards associated in the process and powder handling operations.
- Preparing manufacturing process and process engineering documents with minimal guidance.
- Generating technical data/conclusion through usage of MixIT simulation and Dynochem software. Contributing in lab safety initiatives.
- Having a basic understanding of risks involved in process and powder handling operations.
Qualifications
Bachelor's degree in Chemical Engineering.
Minimum 3 to 6 years of experience with scale up & tech transfer of Active Pharmaceutical Ingredients (API).
Technical skills required include:
- Process scale up of Active Pharmaceutical Ingredients.
- Process Optimization (Manufacturing)
- Process Intensification
- Operational Excellence
- Chemical Process Engineering
- Technology Transfer
Behavioral skills required include:
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to work collaboratively with own team and cross-functional teams.
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