Manager - TSD

We are seeking a Process Engineer / Technology Transfer Manager to support technology transfer, process scale-up, and commercial manufacturing of pharmaceutical/API products. The role involves executing pilot plant, validation, and commercial batches, optimizing manufacturing processes, providing technical support for production, review engineering documentation, participating in HAZOP and process risk assessments, and ensuring compliance with cGMP requirements. The ideal candidate should possess strong process engineering knowledge, problem-solving skills, and the ability to collaborate effectively with cross-functional teams to successfully transfer and commercialize manufacturing processes.

Responsibilities

Execute technology transfer activities from R&D to pilot plant and commercial manufacturing; Evaluate process feasibility for scale-up; Plan and execute pilot plant campaigns, engineering batches, trial batches, and process validation batches; Perform process scale-up activities while ensuring product quality, process safety, and regulatory compliance; Provide technical support for troubleshooting and process optimization; Review Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), and process mapping documents; Conduct HAZOP studies and participate in process risk assessments to identify and mitigate operational hazards; Evaluate process performance, identify bottlenecks, and implement continuous improvement initiatives; Review GMP-compliant documentation, including Batch Manufacturing Records (BMRs), SOPs, and technology transfer documents; Investigate manufacturing deviations, perform root cause analysis, and prepare investigation reports with appropriate CAPA recommendations; Manage Engineering Change Requests (ECRs) and support change control implementation; Coordinate with R&D, Production, Quality Assurance, Quality Control, Engineering, EHS, and Supply Chain teams to ensure successful project execution; Ensure compliance with cGMP, quality systems, process safety, and regulatory requirements throughout the product lifecycle; Support process validation, equipment qualification, and commercial manufacturing activities; Participate in continuous process improvement, cost optimization, and manufacturing efficiency enhancement initiatives

Requirements

Bachelor of Technology (BTech); Strong process engineering knowledge; Problem-solving skills; Ability to collaborate effectively with cross-functional teams