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Plant Engineering-Biologics

5 years

0 Lacs

Posted:1 month ago| Platform: Linkedin logo

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On-site

Job Type

Full Time

Job Description

Job Family: Plant Engineering Sub Job Family: Operation, Repair & Maintenance Preferred type of working: On-Premise Years of Experience: 6 - 12 Business unit: Biologics City- Hyderabad TM - Plant Engineering DS I&A Summary: Experienced Team member to handle Instrumentation & Automation (I&A) function in Drug Substance manufacturing plant. This role plays a critical part in ensuring the smooth operation, efficiency, and regulatory compliance of our biopharmaceutical manufacturing processes. To join a team of technicians responsible for maintaining, troubleshooting, and optimizing a complex network of instrumentation and automation systems. Responsibilities: Implement strategies for the preventative maintenance of all I&A equipment within the Drug Substance manufacturing area. Perform qualification of I&A equipment according to cGMP and regulatory requirements. Troubleshoot and resolve I&A system malfunctions, ensuring minimal disruption to production timelines. Work collaboratively with other engineering personnel, production teams and quality assurance to identify opportunities for process optimization through automation. Stay current on advancements in I&A technology relevant to biopharmaceutical manufacturing. Manage and maintain technical documentation for all I&A systems. Prepare and participate in audits and inspections related to I&A systems. Ensure adherence to all safety regulations and procedures within the manufacturing plant. Qualifications Bachelor's degree in Engineering (in instrumentation/electronics & communication/ electrical/Computer Science) or a related field. Minimum 5 years of experience in a biopharmaceutical or similar aseptic manufacturing environment with a focus on I&A. Proven experience in a technical environment. Strong understanding of cGMP regulations and GAMP® 5 guidelines. In-depth knowledge of biopharmaceutical manufacturing processes and equipment. Experience with common biopharmaceutical manufacturing automation systems (e.g., DCS, SCADA, PLC). Troubleshooting and problem-solving skills. Strong communication, interpersonal, and collaboration skills. Ability to prioritize and handle multiple tasks in a fast-paced environment. TM - Plant Engineering - DS Mechanical Job Description Maintenance and repair of a wide range of biopharmaceutical DS processing equipment, including: Bioreactors Fermentation tanks Tangential Flow Filtration (TFF) systems Chromatography columns Purification skids Aseptic processing equipment Develop and implement preventive maintenance programs to ensure optimal equipment uptime and performance. Troubleshoot equipment malfunctions, diagnose root causes, and implement corrective actions. Manage spare parts inventory and ensure timely procurement of critical materials. Ensure the completion of work orders and ensure adherence to established maintenance procedures and cGMP regulations. Contribute to continuous improvement initiatives by identifying opportunities for equipment optimization and process efficiency. Prepare and maintain detailed maintenance documentation, including logs, reports and procedures. Interface with other departments (e.g., Production, Quality Assurance) to ensure effective communication and collaboration. Training and development of other team members. Ensure a safe work environment for the team by enforcing safety protocols and conducting regular safety training. Qualifications Bachelor's degree in Mechanical Engineering or a related field. Minimum 5+ years of experience in a biopharmaceutical or aseptic manufacturing environment. In-depth knowledge of biopharmaceutical processing equipment and cGMP regulations. Strong understanding of preventive maintenance practices and troubleshooting techniques. Excellent communication, interpersonal, and problem-solving skills. Ability to prioritize tasks, and meet deadlines. Working knowledge of computerized maintenance management systems. Send CV - shrikantsg@drreddys.com Put subject as role above. Show more Show less

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