Process Engineer - Executive

Exemed

Padra

On-site

INR 800,000 - 1,200,000

Full time

3 days ago

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Job summary

Exemed is seeking a Process Technology Transfer specialist to manage technology transfer from R&D to production and between plants. You will evaluate feasibility, design improvements, and coordinate with QA/EHS to ensure manufacturing safety and cGMP compliance.

The role involves planning scale-up, validating batches, and preparing transfer documents such as scale-up reports and P&ID mappings, with a focus on process commercialization and carbon footprint reduction.

Responsibilities

Responsible for process technology transfer from R&D to Plant or one plant to another plant.
Co-ordinate with R&D during the new development and ensure feasibility from plant side before technology transfer.
To assess the process in terms of its feasibility for commercialization.
To evaluate the process and to recommend plant modification based on process requirement.
To prepare and review required details like process block diagram, process flow diagram followed by P&ID
To design and execute any equipment/Plant modification with respect to process requirement.
To observe lab demo batches to evaluate the scale up factor and its feasibility in commercialization.
To evaluate the cost improvement opportunities in the process before/after commercialization.
To support solvent recovery and recycling and its improvement to reduce carbon footprint.
To plan and execute the scale up/ validation batches in commercial plant.
To monitor and collect the scale up and validation batch data for evaluating the commercialization.
To prepare and review required document for technology transfer like scale up report, equipment suitability report and process mapping report.
To Support EHS department for PHA study of process/ product, risk assessments/HAZOP study and to ensure the Process safety at Manufacturing.
To Coordinate with QA department for any deviation, OOS & CAPA against identified nonconformance related to manufacturing for the technical justifications and inferences from data analysis and statistical tools.
To Coordinate with R & D for all the activities related to Scale-up, Technology Transfer and Validation of new products to be introduced in Plants.
To support Production in investigating Product failures/deviations and take necessary corrections, corrective actions and preventive actions. Give necessary guidance and support for effective Production activities, cGMP compliance and QMS system like; change control and deviation, CAPA, OOS, etc. against identified non-conformance related to manufacturing operations.

Job description

Role & responsibilities

Responsible for process technology transfer from R&D to Plant or one plat to another plant.
Co-ordinate with R&D during the new development and ensure feasibility from plant side before technology transfer.
To assess the process in terms of its feasibility for commercialization.
To evaluate the process and to recommend plant modification based on process requirement
To prepare and review required details like process block diagram, process flow diagram followed by P&ID
To design and execute any equipment/Plant modification with respect to process requirement.
To observe lab demo batches to evaluate the scale up factor and its feasibility in commercialization.
To evaluate the cost improvement opportunities in the process before/after commercialization.
To support solvent recovery and recycling and its improvement to reduce carbon footprint.
To plan and execute the scale up/ validation batches in commercial plant.
To monitor and collect the scale up and validation batch data for evaluating the commercialization.
To prepare and review required document for technology transfer like scale up report, equipment suitability report and process mapping report.
To Support EHS department for PHA study of process/ product, risk assessments/HAZOP study and to ensure the Process safety at Manufacturing.
To Coordinate with QA department for any deviation, OOS & CAPA against identified nonconformance related to manufacturing for the technical justifications and inferences from data analysis and statistical tools.
To Coordinate with R & D for all the activities related to Scale-up, Technology Transfer and Validation of new products to be introduced in Plants.
To support Production in investigating Product failures/deviations and take necessary corrections,
corrective actions and preventive actions. Give necessary guidance and support for effective Production activities, cGMP compliance and QMS system like; change control and deviation, CAPA, OOS, etc. against identified non-conformance related to manufacturing operations.