Process Engineer

Mangalam Drugs & Organics; Vapi; On-site; INR 600,000 - 900,000; Full time

Job summary

Mangalam Drugs & Organics is seeking a process engineer to monitor, optimize, and troubleshoot chemical manufacturing processes for APIs and intermediates, ensuring quality and safety.

You will support reactions, crystallization, filtration, drying, distillation, and solvent recovery, driving improvements and collaborating across Production, QA, QC, R&D and EHS teams.

This role emphasizes cGMP compliance, change control, and continuous improvement to reduce waste and costs.

Qualifications

Responsibilities

• Monitor, optimize, and troubleshoot chemical manufacturing processes for APIs and intermediates.
• Provide technical support for reactions, crystallization, filtration, drying, distillation, and solvent recovery operations.
• Optimize process parameters to improve yield, purity, quality, and efficiency.
• Investigate deviations, low yields, impurity formation, and batch failures via root cause analysis.
• Support process scale-up, tech transfer, validation, and commercial batch manufacturing.
• Ensure compliance with cGMP, SOPs, process safety and regulatory requirements.
• Participate in HAZOP, risk assessments, deviation investigations, CAPA, change control.
• Prepare and review batch records, process documents, technical reports, and improvement proposals.
• Coordinate with Production, QA, QC, R&D, Engineering, and EHS teams to resolve issues.
• Implement continuous improvement to reduce batch cycle time, solvent use, waste, and costs.
• Monitor process performance and implement corrective/preventive actions to ensure quality and safety.

Job description

Role & responsibilities

• Monitor, optimize, and troubleshoot chemical manufacturing processes for APIs and intermediates.
• Provide technical support for reactions, crystallization, filtration, drying, distillation, and solvent recovery operations.
• Optimize process parameters to improve product yield, purity, quality, and manufacturing efficiency.
• Investigate process deviations, low yields, impurity formation, and batch failures through root cause analysis.
• Support process scale-up, technology transfer, process validation, and commercial batch manufacturing.
• Ensure compliance with cGMP guidelines, SOPs, process safety standards, and regulatory requirements.
• Participate in HAZOP studies, risk assessments, deviation investigations, CAPA, and change control activities.
• Prepare and review batch manufacturing records, process documents, technical reports, and improvement proposals.
• Coordinate with Production, QA, QC, R&D, Engineering, and EHS teams to resolve process-related issues.
• Implement continuous improvement initiatives to reduce batch cycle time, solvent consumption, waste generation, and manufacturing costs.
• Monitor process performance and implement corrective and preventive actions to ensure product quality, operational safety, and improved productivity.