Job
Description
As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will lead the process engineering aspects of pharmaceutical plant projects. Your responsibilities include overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. - Lead the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. - Develop and review essential documents including P&ID, Process Flow Diagrams, Mass Balances, Equipment Sizing, and Critical Design Parameters. - Prepare and evaluate User Requirement Specifications (URS) and oversee various tests and validation protocols such as FAT, SAT, DQ, IQ, OQ, and PQ to ensure compliance with regulatory standards like GMP, WHO, USFDA, and EU. - Collaborate with cross-functional teams such as R&D, Quality Assurance, HVAC, Utility, Electrical, Instrumentation, and Automation. - Provide technical expertise and leadership during project execution, commissioning, and regulatory audits. - Conduct client meetings, technical presentations, troubleshooting activities, and international travel for projects, site visits, audits, and technical review meetings. To qualify for this position: - Hold a Bachelor's or Master's degree in Chemical Engineering or Pharmaceutical Engineering. - Have 8 to 12 years of experience in process design and execution of pharmaceutical plant projects. - Possess a deep understanding of regulatory requirements including GMP, WHO, USFDA, and EU. - Demonstrate leadership skills in managing diverse teams and external consultants/vendors. - Exhibit excellent communication, documentation, and presentation abilities. - Showcase the capability to handle multiple projects under strict timelines. - Possess a valid passport, and prior international exposure is highly desirable. As a Process Head at Kavs Spectronova Technologies Pvt Ltd, you will lead the process engineering aspects of pharmaceutical plant projects. Your responsibilities include overseeing optimal process design, ensuring regulatory compliance, and facilitating seamless coordination among internal and external stakeholders for both greenfield and brownfield facility projects within the pharmaceutical industry. - Lead the end-to-end process design for various types of pharmaceutical facilities such as OSD, Injectable, Vaccine, or Biotech. - Develop and review essential documents including P&ID, Process Flow Diagrams, Mass Balances, Equipment Sizing, and Critical Design Parameters. - Prepare and evaluate User Requirement Specifications (URS) and oversee various tests and validation protocols such as FAT, SAT, DQ, IQ, OQ, and PQ to ensure compliance with regulatory standards like GMP, WHO, USFDA, and EU. - Collaborate with cross-functional teams such as R&D, Quality Assurance, HVAC, Utility, Electrical, Instrumentation, and Automation. - Provide technical expertise and leadership during project execution, commissioning, and regulatory audits. - Conduct client meetings, technical presentations, troubleshooting activities, and international travel for projects, site visits, audits, and technical review meetings. To qualify for this position: - Hold a Bachelor's or Master's degree in Chemical Engineering or Pharmaceutical Engineering. - Have 8 to 12 years of experience in process design and execution of pharmaceutical plant projects. - Possess a deep understanding of regulatory requirements including GMP, WHO, USFDA, and EU. - Demonstrate leadership skills in managing diverse teams and external consultants/vendors. - Exhibit excellent communication, documentation, and presentation abilities. - Showcase the capability to handle multiple projects under strict timelines. - Possess a valid passport, and prior international exposure is highly desirable.
