![]() The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Specific vision abilities required by this job include close vision, distance vision, and color vision. The employee must occasionally lift and or move up to 55 pounds. The employee is occasionally required to reach with hands and arms climb or balance stoop kneel crouch. The employee is frequently required to walk sit use hands talk and hear. While performing the duties of this job, the employee is regularly required to stand. Strong collaboration skills to work effectively across teams and with stakeholders. Strong organizational and demonstrated leadership skillsĮxcellent verbal and written communication skillsĮxcellent problem-solving skills and ability to work under pressure. ![]() Proficiency in troubleshooting and repairing mechanical, electrical, and automation systems. Knowledge of Utility systems and HVAC systems. Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (cGMP, FDA guidelines). Minimum 5 years of experience repairing and maintaining pharmaceutical manufacturing and packaging equipment (oral solid dosage experience preferred). Provide suggestions for change.īachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related field. Review structural blueprints for new projects. Set up and operate all tools and equipment necessary to perform assigned work.Īssign work and resolve routine problems within the Maintenance Department. Provide technical support and training to operators and technicians on proper equipment operation and maintenance.Īdhere to and promote a strong safety culture by following all safety procedures and protocols.Įnsure that maintenance activities are conducted in compliance with environmental, health, and safety regulations.Īssist in commissioning or qualification activities of site equipment, building, and utility systems. Implement and participate in continuous improvement initiatives, including lean manufacturing and Six Sigma projects.Ĭollaborate with cross-functional teams, including production, and quality control, to align maintenance activities with production goals and quality standards. Identify opportunities for process improvement, reliability enhancement, and cost reduction in collaboration with the engineering and production teams. Write SOP, protocols, and maintenance reports for manufacturing and utility equipment.Īuthoring equipment specifications, user and functional requirements specifications, and necessary FAT.Įnsure compliance with regulatory guidelines and company SOPs (Standard Operating Procedures) for maintenance and engineering practices. Maintain accurate records of maintenance activities, including work orders, equipment history, and maintenance schedules. Maintain inventory of parts required for preventative maintenance.Ĭoordinate with suppliers and vendors for spare parts procurement and ensure timely availability of critical components. Respond promptly to equipment breakdowns and emergencies, working with urgency to restore operations while adhering to safety protocols.Ĭonduct routine, periodic, or special inspections to determine repair and maintenance work necessary to prevent breakdowns of facilities' machinery and utility equipment.Ĭollect quotations from vendors and create purchase requisitions for spare and repair parts. Troubleshoot and diagnose equipment issues, perform root cause analysis, and implement effective solutions to minimize downtime. The Maintenance Engineer collaborates with cross-functional teams to maintain equipment reliability, optimize performance, and uphold safety and quality standards.Ĭonduct routine inspections, preventive maintenance, and repairs on pharmaceutical manufacturing equipment, including but not limited to mixing machines, compression machines, encapsulation machines, coating machines, and packaging machines. This role requires a strong understanding of mechanical, electrical, and automation systems and a deep knowledge of pharmaceutical manufacturing processes and regulatory requirements. The Maintenance Engineer plays a critical role in ensuring the smooth operation and maintenance of all equipment, machinery, and facilities within the pharmaceutical manufacturing plant.
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