Filling Instrumentation Engineer
PharmaBiotechRegulatory AffairsQuality Assurancegmpgdpcroinform
Job description
Use Your Power for Purpose Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you'll play a key role in accelerating the delivery of medicines to the world. Your innovative ideas and proactive actions will help us imagine new possibilities and bring them to life, ensuring that vital medications reach those in need more swiftly and efficiently. Your contributions will be instrumental in enhancing manufacturing information systems, boosting success rates, and ensuring zero downtime. By integrating manufacturing processes, operational knowledge, equipment control, and data into cohesive systems, you will enforce seamless operations across various departments. Your dedication will be pivotal in meeting project objectives and goals, fostering a collaborative team environment, and driving your colleagues towards success. 1. Position Overview The Equipment Maintenance Engineer (J40B) plays a critical role in ensuring uninterrupted, safe, and compliant operation of pharmaceutical manufacturing assets across Upstream, Downstream, Utilites, and Fill–Finish areas. This position requires hands-on troubleshooting, preventive and predictive maintenance execution, calibration activities, documentation compliance, and participation in continuous improvement & engineering projects. 2. Detailed Responsibilities 2.1 Functional Responsibilities - Strictly adhere to site EHS guidelines, LOTO procedures, safe work practices, and participate in hazard identification & risk assessments. - Lead or support issuance, execution, and closure of work permits (General, LOTO, Hot Work, Height Work, Confined Space). - Perform detailed root cause analysis for equipment failures and support CAPA development, deviation investigations, and change control documentation. - Manage preventive maintenance plan execution in EAMS/CMMS, ensuring work orders, spare consumption, and task completion records are accurately updated. - Monitor equipment health parameters, component wear trends, and propose predictive maintenance actions. - Support engineering projects related to equipment upgrades, safety enhancements, automation improvements, and capacity expansions. - Maintain 5S, workplace organization, and visual management standards across maintenance workshops and equipment areas. 2.2 Technical Responsibilities - Conduct preventive, breakdown, and predictive maintenance for mechanical, electrical, and instrumentation systems across Solution Prep, Vial Washing, Tunnel Sterilization, Filling, Capping, Inspection, and Packaging areas. - Calibrate field instruments including transmitters, sensors, gauges, flowmeters, control valves, and analytical instruments as per GMP procedures. - Perform mechanical alignments, shaft coupling, lubrication, pump overhauling, pneumatic system troubleshooting, and equipment balancing. - Troubleshoot PLC, SCADA, and DCS system–related alarms under guidance; assist in automation upgrades and FAT/SAT activities. - Support installation, commissioning, and qualification of new equipment (IQ/OQ/PQ), ensuring documentation accuracy and compliance. - Execute shut-down maintenance activities including equipment dismantling, inspection, refurbishment, and reassembly. - Ensure availability and proper management of spares, consumables, and critical parts by coordinating with Stores and Procurement teams. 2.3 Behavioral Attributes - Demonstrate strong communication skills, ensuring accurate reporting, escalation, and coordination with Operations, Quality, and Engineering teams. - Take ownership during equipment failures, respond promptly to urgent issues, and support cross-functional troubleshooting efforts. - Actively participate in knowledge-sharing discussions, train operators on basic troubleshooting, and mentor junior technicians. - Support a culture of integrity, speak up when observing non-compliances, and reinforce good documentation practices. - Maintain positive team collaboration, adaptability to dynamic manufacturing environments, and contribute to a culture of continuous improvement. 3. Essential Qualifications & Experience - Diploma or B.Tech in Mechanical, Instrumentation, or Electronics Engineering. - Industrial Experience: 6–7 years (Diploma) or 1–3 years (B.Tech) in regulated pharma/biotech/chemical industry. 4. Core Competencies - Understanding of GMP, GDP, GEP, and pharmaceutical regulatory expectations. - Working knowledge of equipment qualification, calibration, and validation principles. - Ability to interpret P&IDs, electrical drawings, loop diagrams, and OEM manuals. - Problem-solving capability using PDCA, fishbone analysis, 5-Why, and lean tools. - Foundational knowledge of risk-based maintenance and equipment criticality ranking. 5. Desirable Requirements <span style="color:#000000
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