Process Engineering - Manager(Bidar)

SAI Life Sciences; Bidar District; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

SAI Life Sciences is seeking an experienced Plant Process Engineering leader to drive production growth and ensure compliance with safety and quality norms. The role coordinates with production, engineering, QC, R&D, PPIC, SCM and project teams to meet timelines and budgets.

You will guide scale-up validation, evaluate process changes, and lead debottleneck studies, while improving yields and batch efficiency. Strong collaboration with cross-functional teams is essential.

Responsibilities

• Lead the plant process engineering function to meet production quantities and timelines coordinating with Production, Engineering, QC, R&D, PPIC, SCM, and Project Management.
• Ensure site safety, cGMP compliance, and training; motivate and place personnel in appropriate roles.
• Evaluate scale-up parameters, complete scale-up validation, and support production for commercial manufacturing.
• Review proposed process/equipment changes with justification; update documents (BPR, change summaries, process risk assessments, P&ID, PSSR, campaign reports).
• AIM to achieve process metrics such as yield, batch cycle time, and batch charging frequency.
• Conduct debottleneck studies and capacity assessments for regular products to meet production goals.
• Support manufacturing during troubleshooting with technical inputs for investigations.
• Collect and analyze data to generate process capability trends for knowledge sharing with CFTs.
• Drive cost-initiative programs like solvent recovery, yield improvements, process intensifications, and operability.
• Compile management data (equipment, facility, product, cost) and correlate for improved operations and capacity planning.
• Evaluate plant utilities for effective utilization.
• Participate in client calls/audits providing technical information and justifications.
• Understand new processes/ tech transfer during walk-throughs and align facilities accordingly.
• Review change control for site initiation for repeat campaigns of commercial products.
• Assess process with respect to quality, safety, yields, waste management; coordinate with PE & PR&D for smooth batch execution.
• Verify data on critical parameters, purity, yield and batch cycle time before new campaigns.
• Report deviations/observations immediately to superiors and concerned persons.
• Complete investigations (Product deviation & OOS) related to the process.
• Assign work and monitor subordinate personnel.
• Explore new technologies for commercial projects and improvements.

Job description

Role & responsibilities

1. Responsible for leading the plant process engineering function to achieve planned production quantities and timelines as per customer requirements by coordinate with respective CFTs like Production, Engineering, QC, R&D, PPIC, SCM and Project Management etc.

2. Responsible for Process Engineering team to follow the site level safety norms & cGMP requirements, internal team trainings, motivation and identify the skill/expertise of personnel and ensure them in right job.

3. Responsible for evaluating the Scale Up parameters, completion of scale-up validation, and support to production for commercial manufacturing.

4. Evaluating the proposed changes of process, equipment and accordingly provide the equipment suitability or comparison with proper justifications. Reviewing and correcting of documents like BPR, CCF-change summary, process risk assessment, P&ID, PSSR, Campaign reports etc.

5. Responsible for achieving the process metrics like Budgeted Yield, Batch Cycle Time, Batch Charging Frequency.

6. Perform the de-bottleneck study of regular products and its capacity assessments to meet the production goals.

7. Support to manufacturing in trouble shooting to provide technical inputs during incident investigations.

8. Responsible for data collection and its assessment to generate the trend data of process capability and data presentations to CFTs for knowledge sharing.

9. Responsible for, implementation of management cost-initiative activities like solvent recovery and recycle, Yield improvements, & Process intensifications and Operability.

10. Responsible for collecting all management information like equipment, facility, product, cost etc and correlate them for better operations/easy of operations/capacity enhancement/ new facility creations/Capex preparations.

11. Evaluation plant utilities and its effective utilization.

12. Participating and providing the technical information or justifications during client calls or customer audits.

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

14. Responsible to review the change control for site initiation for Repeat Campaign of commercial products.

15. 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 with right first-time manner.

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

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

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

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

20. Exploring the new technologies for the commercial projects and improvements.