8.0 - 12.0 years

0 Lacs

indore, madhya pradesh

On-site

The position you are applying for will involve managing utility systems in injectable facilities, overseeing operations, ensuring compliance with regulations, and implementing efficient facility management practices. You will be responsible for leading the execution of greenfield/brownfield injectable facility projects from start to finish, which includes tasks such as design, budgeting, procurement, construction, commissioning, and qualification. Your duties will also include overseeing critical utility systems such as WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems to ensure they operate smoothly and meet compliance standards. It will be your responsibility to ensure that all systems and documentation adhere to cGMP, GEP, and regulatory standards such as USFDA, EU-GMP, and WHO-GMP. You will also need to prepare for and support audits and inspections. Collaboration with QA, Production, Validation, and EHS teams will be essential to align project deliverables with operational and compliance requirements. You will also be required to evaluate and manage third-party vendors, consultants, and contractors to ensure the timely and quality execution of projects. Driving initiatives for energy optimization, water conservation, and sustainable engineering practices will be part of your role. Additionally, you will need to mentor and lead a team of project engineers and utility specialists while fostering a culture of accountability, safety, and continuous improvement. Qualifications for this position include a Bachelor's or Master's degree in engineering (Mechanical/Electrical/Chemical/Instrumentation) from a recognized institution. Required skills for this role include a deep understanding of critical utility systems, regulatory guidelines, project budgeting, vendor evaluation, contract management, commissioning, qualification, engineering documentation, risk assessments, and audit readiness. Strong interpersonal and leadership skills are also necessary to effectively manage cross-functional teams. Preferred skills that would be beneficial for this position include experience with automation systems, exposure to sustainability programs and energy conservation initiatives, proficiency in engineering tools and design software (such as AutoCAD and MS Project), as well as knowledge of lean engineering and continuous improvement methodologies.,

Posted 1 month ago

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Sr Manager / AGM Sun Pharma

25.0 - 28.0 years

25 - 30 Lacs

bengaluru

Work from Office

Role & responsibilities To manage bio tech manufacturing plant engineering projects & maintenance. To ensure the adequate utilization of man resources. To manage the operating cost with optimal usage of spares/consumables To manage the capital expenditure planed for capacity enhancement, replacement of existing assets, improving the efficiency of operation.by employing latest technology To plan for revenue/capital expenditures. To keep the facility in all time readiness for local cGMP inspection. homogenizer To have in-depth knowledge of bio tech manufacturing plant equipments (Fermenters, Continuous centrifuge, Homogenizer, mixing vessels, CIP process, steam sterilizers). To have in-depth knowledge process utilities generation & distribution systems (Water generation system-WFI, Pure steam, Purified water system, Compressed air, Chillers, Steam boilers (HSD fired & Bio briquette fired) Well versed with project management for facility upgradation, PID preparation, project chart preparation, BOQ preparation, Budgeting of project & meeting the targeted time lines. Preferred candidate profile To have knowledge of cGMP requirement for HVAC, area maintenance, area classification, Building management system, To have knowledge of process control systems, PLC, data loggers, SCADA system involved in manufacturing & utility systems. To have the knowledge of qualification & validation process of manufacturing & utility equipments. Know about the water system management treatment for meeting the process requirement as per norms. To have in-depth knowledge of CDSCO / EU guidelines for equipment/facility maintenance. To have knowledge of quality management tools like Track wise, SAP, Enterprise data management system (EDMS). Learning management system. Well versed with EHS regulation & compliances Well versed with electrical regulations/standards, boiler, pressure vessel regulations. Liasoning with external /internal stake holders for delivering the company objective.

Posted Date not available

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