Associate Manager

Description

• Perform routine and preventive maintenance on Downstream areas: Sterilization, Visual Inspection, Packaging and Microbiology equipment.
• Troubleshooting of Major technical issues & handle Complex technical issues of: Sterilization, Visual Inspection, Packaging and Microbiology equipment.
• Lead and oversee preventive, predictive, and corrective maintenance activities for critical process equipment such as reactors, centrifuges, granulators, dryers, and tablet presses.
• Ensure all maintenance activities comply with GMP, FDA, and other regulatory requirements.
• Troubleshoot and resolve complex mechanical, electrical, and automation-related equipment issues.
• Develop and optimize maintenance SOPs, checklists, and documentation in alignment with quality standards.
• Coordinate with cross-functional teams during equipment qualification, validation, and change control processes.
• Analyze equipment performance data to identify trends, root causes of failures, and opportunities for reliability improvement.
• Manage spare parts inventory and vendor relationships for timely procurement and support.
• Mentor junior engineers and technicians, and lead training initiatives on equipment maintenance best practices.
• To perform FMEA & RCA and effectively trend equipment breakdowns and guide to implement corrective actions for improving reliability, here's a structured approach based on best practices in reliability engineering and maintenance management
• Calibrate instruments such as pressure gauges, temperature sensors, flow meters, and analytical instruments.
• Work with different types of PLCs, SCADA, and other PC based Automation systems used in pharmaceutical manufacturing.
• Support for automation projects and equipment upgrades
• Performing proactive maintenance activities to improve efficiency of downstream equipment.

Qualifications

• Qualification: Diploma or B. Tech in Instrumentation or Electronics Engineering.
• Experience: Diploma with 10-12 years industrial experience or B. Tech with 7-8 years industrial experience.
• Pharmaceutical Process Equipment Expertise In-depth knowledge of operation, maintenance, and troubleshooting of equipment.
• GMP & Regulatory Compliance Strong understanding of Good Manufacturing Practices (GMP), FDA, MHRA, and other regulatory requirements governing pharmaceutical manufacturing.
• Preventive & Predictive Maintenance Proficient in developing and executing preventive and predictive maintenance strategies to minimize downtime and extend equipment life.
• Root Cause Analysis (RCA) Skilled in conducting failure investigations and implementing corrective and preventive actions (CAPA) to address recurring equipment issues.
• Computerized Maintenance Management Systems (CMMS) Hands-on experience with CMMS platforms for scheduling, tracking, and documenting maintenance activities.
• Equipment Qualification & Validation Support Familiar with IQ/OQ/PQ protocols and supporting validation activities for new and existing equipment.
• Technical Documentation & SOP Development Ability to create and maintain detailed maintenance SOPs, equipment logs, and compliance documentation.
• Cross-Functional Collaboration Effective communication and coordination with production, quality assurance, engineering, and external vendors.
• Continuous Improvement & Reliability Engineering Focused on identifying opportunities for process and equipment optimization using tools like FMEA, TPM, and Six Sigma