Job Profile- Engineering Manager Location- Noida Company Description MedTherapy Biotech is a Boston based cell, gene and immunotherapy company working in collaboration With Harvard Medical School, Merck KGaA and others. It was founded by cancer experts from Harvard University and former Novartis executives. MedTherapy's mission is to make cancer gene therapy affordable and accessible globally. Role Description We are looking for a well-established expert in the area of Engineering department, Plant maintenance, IBR Boiler and in Green field project for Injectable/OSD with strong scientific credentials who are aligned with our noble mission. The candidate should be driven to attain the highest standards of success with integrity. The position entails the major roles and responsibilities including: Audit and compliance, Legal compliance, Responsible for Vendor qualification of sterile and non sterile consumables items Responsible for technical supports to plants and for qualification of SWFI vendor. Qualifications Planning and Monitoring of day to day engineering activities at the MedTherapy India Preparing SOP for engineering operations, maintenance and operating procedure of all utility equipment's. To attend to the breakdown of plant and utility equipment's. Plan and implementation of preventive maintenance schedules , Instrument Calibration schedules for process equipment and plant machinery. To maintain PM records, breakdown Job cards, Calibration reports. All time readiness for regulatory audits and Visits Cent percent compliance on GXP and EHS. Implementation of various projects as per requirements. Installation and commissioning of all NEW Equipments Project planning, scheduling and monitoring . Execution of QMS documents Any other Job allocated by Reporting Manager KEY SKILLS NEEDED Sounds Technical Knowledge on Overall Engineering Services ( Mechanical, Electrical, Instrumentation ) operations in Biotech Manufacturing Organization. Sound experience in cGEP ( Good Engineering Practices) Experience in Regulatory Audits and Visits Exposure of legal compliance of PCB, Electricity board and other agencies Maintenance of clean utility and utility system Managerial Skills Education and experience requirements Candidate MUST have the minimum level of (Bachleor in Mechanical Engineering with 10-15 years of experience) in the areas of Engineering Services at Biotech Manufacturing Industry. Preference given to candidates who have worked in BIOTECHNOLOGY especially in a GMP commercial manufacturing environment. If Interested and feel right fit, please reach out to [HIDDEN TEXT] , [HIDDEN TEXT]