Process Engineer

Role & responsibilities

• Design, implement, and optimize processes for new and existing products
• Develop and execute process validation protocols
• Collaborate with cross-functional teams to ensure product quality and regulatory compliance
• Troubleshoot process issues and implement corrective actions
• Develop and maintain process documentation, including SOPs and batch records
• Identify opportunities for process improvement and implement changes
• Support scale-up and technology transfer activities
• Ensure compliance with cGMP, regulatory requirements, and company policies
• Development of new product, improving the existing product and process in R&D lab. •
• Interaction with the R&D development team from initial stage to understand the process and to provide engineering inputs with respect to unit operations involved in the process.
• To observe and understand R&D process in the lab for 3 consecutive batches and to generate data for scale up and to identify loopholes.
• Preparing Objectives for scale up trials, its observations, recommendations and conclusion.
• Absorb technology from R&D and to Scale up processes (upto 5 kg) with minimum failure.
• Technology transfer from scale up to pilot plant and to validate the process for 3 consecutive batches in pilot plant.
• Identification of critical parameters and its suggestions and implementation in the plant SOP.
• Process trouble shooting in manufacturing.
• Planning and Taking care of shift activities as per cGMP.
• Co-ordinating with Stores and Purchase departments for obtaining RM, intermediates and consumable whenever required.
• Coordinate with maintenance regarding-breakdown and preventive maintenance of equipments or facility.
• To ensure right equipment selection as per process requirement.
• Calculation of Power Requirement for Pump and Agitator, Agitator Tip Speed, Volume Calculation, Process Time Cycle Calculation and Raw Material Costing
• Development of new product, improving the existing product and process in R&D lab.
• Line sizing for Liquids & Gases & Pressure drop calculations
• Pump Hydraulics Calculations
• Control Valves Sizing

Preferred candidate profile

• Bachelor's/Master's degree in Engineering, Pharmaceutical, or related field
• Min. 12 years of experience in a pharmaceutical or related industry
• Experience with process validation, scale-up, and technology transfer
• Strong knowledge of cGMP regulations and industry standards
• Excellent problem-solving, communication, and project management skills
• Proficiency in MS Office and process simulation software

Preferred Skills:

• Experience with pharma, aerosol and cosmetic products
• Knowledge of regulatory requirements for pharmaceutical and cosmetic products
• Experience with process analytical technology (PAT)
• Familiarity with Lean/Six Sigma methodologies