TAT & Process Engineering

SAI Life Sciences; Bidar District; On-site; INR 600,000 - 900,000; Full time

Job summary

SAI Life Sciences in India, Karnataka, Bidar district, is seeking a role focused on process transfer and manufacturing readiness. You will understand new processes, plan line modifications, review change controls, and assemble essential documents for batch execution.

The position requires coordinating with Warehouse, Engineering, QC, PR&D, HSE and QA to start up on time, maintaining quality and safety while meeting dispatch targets.

Responsibilities

• Understand new process and tech transfer during walk-through; ensure facility readiness.
• Plan and complete line modification activities per execution plan.
• Review change control for site initiation of new product/stage/campaign.
• Arrange documents like Tech pack, Risk assessment, PSSR, PID for batch execution.
• Coordinate with Warehouse, Engineering, QC, Process Eng, PR&D, HSE & QA to start up on time.
• Review processes for Quality, Safety, Yield, Waste management and utilities availability.
• During initiation, train subordinates and production team.
• Track batch status w.r.t Quality, Yield, Cycle time against dispatch timeline.
• Verify data for critical parameters, purity, yield before new campaigns.
• Report deviations/observations immediately to superiors and concerned personnel.
• Complete investigations (Product deviation & OOS) related to process.
• Provide technical troubleshooting during process execution.
• Ensure safety practices and guide subordinates accordingly.
• Ensure RM stock available in advance for batch charging to meet targets.
• Assign jobs and monitor subordinate activities.

Job description

Role & responsibilities

1. Responsible to understand the New process/ Tech transfer during the walk through and ensuring the facility accordingly.


2. Responsible to Plan and completing line modification activities as per Execution plan (based on the process requirement).


3. Responsible to review the change control for site initiation for New Product/ Stage/ Campaign. Accordingly arranging the other documents to execute batch in the plant like Tech pack, Risk assessment, PSSR, PID etc.


4. Responsible for co-ordinating with other departments like Warehouse, Engineering, QC, Process Engineering, PR&D, HSE & QA to complete start up activities as per the time line.


5. Review process with respect to Quality, Safety, Yield, and Waste management, availability of Utility source and accessories. Collecting relevant details from PE & PR&D to execute the batch smoothly.


6. During initiation of New product/ stage or change in process, training shall be imparted to concern subordinates and Production team.


7. Responsible to track the batch status w.r.t Quality, Yield, Cycle time according to dispatch time line by co-ordination with Production team.


8. Verifying data with respect to critical parameters, purity and yield along with batch cycle time of previous batches before executing new campaign / batches.


9. Responsible to report the deviations/ observations /abnormalities immediately to Superiors & Concern persons.


10. Responsible to complete the investigation (Product deviation & OOS) w.r.t process.


11. Responsible for technical troubleshooting the problem arised during process execution.


12. Responsible for ensuring safety practices & instruct to subordinates for the same.


13. Responsible to ensure the RM approved stock availability in advance for batch charging to meet dispatch target.


14. Responsible for assigning job and monitoring subordinate persons activities.