
Process Engineer
2 weeks ago
Roles & Responsibilities
- To complete the Assigned trainings in Learning Management System (LMS).
- To prepare technical justifications for changes in equipment and batch size.
- To review the performance qualification protocols and reports.
- To prepare the PFD for facility modifications and change controls.
- To prepare Quality Risk Assessment, Continuous Process Verification's reports.
- To coordinate for the execution of Trial and validation batches for all modified, new process and involve in commercial batches trouble shooting.
- To involve in cycle time reduction and cost reduction activities in Co-ordination with other departments.
- To prepare the equipment matrix and product mapping matrix.
- To Involve in the investigations as a cross functional team.
- Trending the quality and operational parameters data for investigation.
- Trending of the quality details of the batch from the Chromatogram.
- To prepare and compile the investigation reports.
- Initiating protocols for study of different in-process parameters for process improvement and trouble shooting.
- Tracking of incident investigations and CAPAs
- To perform and coordinate the Process Safety Information.
- To perform and coordinate the Process Hazard analysis and safety Risk assessment.
- To coordinate the PSSR.
- To attend the cGMP training and internal training [SOPs, Critical Process Parameters, cGMP and Operational safety] classes without fail.
- To undertake any other job as may be assigned by the concerned Department Head.
- 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 to Evaluate and establish possibilities of solvent, reagents and product recoveries.
- 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.
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
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to work collaboratively with own team and cross-functional teams.
Benefits Offered
Our Work Culture
Dr. Reddy's Laboratories
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