Padmi

Executive - Process Engineering

IndiaPosted 3 months ago
Engineering ManagementStaff+Full Time; Regular
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Role Overview: As an Executive - Process Engineering at PPL Pharma Inc., you will be responsible for leading and optimizing manufacturing processes to ensure efficiency, quality, and compliance within pharmaceutical production facilities. Your role will involve driving continuous improvement initiatives and technological advancements in the processes. Key Responsibilities: - Oversee the design, development, and optimization of pharmaceutical manufacturing processes from concept to commercialization. - Lead a team of process engineers, providing technical guidance, mentorship, and performance management. - Identify and implement process improvements to enhance yield, reduce costs, increase efficiency, and ensure product quality. - Develop and manage process validation strategies and protocols in compliance with cGMP regulations and industry standards. - Collaborate cross-functionally with R&D, Quality Assurance, Manufacturing Operations, and Regulatory Affairs to ensure seamless process integration and product transfer. - Conduct root cause analysis for process deviations and implement effective corrective and preventive actions (CAPAs). - Evaluate and implement new technologies and equipment to improve process capabilities and capacity. - Prepare and review technical documentation, including process flow diagrams, P&IDs, batch records, and standard operating procedures (SOPs). - Ensure all process engineering activities adhere to safety, environmental, and regulatory requirements. - Manage project timelines, budgets, and resources for process engineering initiatives. Qualifications Required: - Bachelor's or Master's degree in Chemical Engineering. - Minimum of 3 - 7 years of progressive experience in process engineering within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or managerial role. - Extensive knowledge of cGMP, FDA, EMA, and other relevant regulatory guidelines. - Proven track record of successful process development, optimization, and validation projects. - Strong understanding of various unit operations in pharmaceutical manufacturing (e.g., mixing, filtration, purification, lyophilization, tablet compression). - Experience with process analytical technology (PAT) and statistical process control (SPC). - Excellent analytical, problem-solving, and decision-making skills. - Exceptional leadership, communication, and interpersonal skills with the ability to influence and collaborate effectively at all levels. - Proficiency in process simulation software and data analysis tools is a plus. Role Overview: As an Executive - Process Engineering at PPL Pharma Inc., you will be responsible for leading and optimizing manufacturing processes to ensure efficiency, quality, and compliance within pharmaceutical production facilities. Your role will involve driving continuous improvement initiatives and technological advancements in the processes. Key Responsibilities: - Oversee the design, development, and optimization of pharmaceutical manufacturing processes from concept to commercialization. - Lead a team of process engineers, providing technical guidance, mentorship, and performance management. - Identify and implement process improvements to enhance yield, reduce costs, increase efficiency, and ensure product quality. - Develop and manage process validation strategies and protocols in compliance with cGMP regulations and industry standards. - Collaborate cross-functionally with R&D, Quality Assurance, Manufacturing Operations, and Regulatory Affairs to ensure seamless process integration and product transfer. - Conduct root cause analysis for process deviations and implement effective corrective and preventive actions (CAPAs). - Evaluate and implement new technologies and equipment to improve process capabilities and capacity. - Prepare and review technical documentation, including process flow diagrams, P&IDs, batch records, and standard operating procedures (SOPs). - Ensure all process engineering activities adhere to safety, environmental, and regulatory requirements. - Manage project timelines, budgets, and resources for process engineering initiatives. Qualifications Required: - Bachelor's or Master's degree in Chemical Engineering. - Minimum of 3 - 7 years of progressive experience in process engineering within the pharmaceutical or biotechnology industry, with at least 3 years in a leadership or managerial role. - Extensive knowledge of cGMP, FDA, EMA, and other relevant regulatory guidelines. - Proven track record of successful process development, optimization, and validation projects. - Strong understanding of various unit operations in pharmaceutical manufacturing (e.g., mixing, filtration, purification, lyophilization, tablet compression). - Experience with process analytical technology (PAT) and statistical process control (SPC). - Excellent analytical, problem-solving, and decision-making skills. - Exceptional leadership, communication, and in

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