Purpose The Electrical/Mechanical/Instrumentation Engineer will be responsible for operation, maintenance, and compliance of Electrical/Mechanical/Instrumentation systems across OSD manufacturing and packaging areas. The role includes manufacturing equipment preventive/breakdown maintenance, calibration, shift operation responsibility, documentation of all GMP activity. Active participation in regulatory and Quality Management System (QMS) documentation in accordance with cGMP requirements. Position / Job Title Sr. Officer – Manufacturing Maintenance, Engineering Department Engineering/Technical services Reporting To Manager, Engineering Location Pithampur Years of Experience
• 02–05 years of experience in OSD Plant maintenance and troubleshooting Dosage Form Solid & Semi solid Job Responsibilities / Deliverables
• Manufacturing Process Equipments Maintenance & Troubleshooting
• Perform operation, preventive, and breakdown maintenance of manufacturing process equipment, including: oGranulation lines (RMG, FBD, Mill, Blender) oDispensing units and material handling systems oCoating machines (Auto coaters) oCompression machines oTrack & Trace systems oPrimary packaging areas (Blister, Strip, Bottle lines etc.) oSecondary packaging areas (Cartoner, BPU, Case packer, Serialization equipment etc.)
• Ensure minimum downtime and high equipment availability through timely troubleshooting and root cause analysis. Maintain shift wise report and update MTBF and MTTR accordingly.
• Support continuous manufacturing operations with prompt response to breakdowns.
• Handle modifications, upgrades,



and retrofits of manufacturing equipment as per approved change controls.
• Tracking of PM schedule and completing the PM activity within schedule online in E log software.
• Calibration Management
• Ensure compliance with calibration schedules for instruments used in manufacturing, warehouse and quality Control.
• Review calibration results and support investigation of out-of-tolerance (OOT) conditions.
• Initiate and close calibration-related deviations, RCA, and CAPA in collaboration with QA.
• EHS & Statutory Compliance
• Ensure adherence to safety norms, statutory guidelines, and site EHS policies.
• Implement and monitor LOTO practices, permit-to-work systems, and use of electrical PPE.
• Participate in electrical safety audits, EHS inspections, and incident investigations.
• Maintain compliance of earthing, lightning protection, and electrical safety testing.
• Regulatory & QMS Documentation
• Actively participate in QMS activities related to engineering and manufacturing, including: oChange Control (CC) oDeviation and incident handling oCAPA implementation and effectiveness review
• Prepare, review, and maintain SOPs, logbooks,



and technical documentation for process equipment systems.
• Support regulatory audits and inspections (USFDA, WHO, MHRA, EU) by providing technical inputs and maintaining documentation.
• Qualification & Validation Support
• Support IQ/OQ/PQ and requalification activities for manufacturing equipment, utilities, and control systems.
• Coordinate with QA and Validation teams to ensure compliance with validated state requirements.
• Continuous Improvement
• Drive improvement initiatives related to equipment reliability, energy efficiency, and maintenance optimization.
• Analyse recurring failures and implement preventive measures.
• Support digitization and predictive maintenance initiatives. Qualifications Education
• Bachelor’s degree in Electrical/Mechanical/Instrumentation (mandatory). Additional NotesSkills & Competencies
• Robust understanding of OSD manufacturing equipment systems
• cGMP and regulatory compliance knowledge
• Calibration and validation exposure
• Documentation and audit readiness mindset
• Effective coordination with Production, QA, Validation, and EHS teams
• Ability to read engineering drawings (P&ID;, Electrical drawings, layout).
• Exposure to regulatory audits: USFDA, EU-GMP, WHO.
• Familiarity with QMS software / electronic PM software is an advantage. Key Performance Indicators (KPIs)
• Zero Quality Incidents
• 100% adherence of PM Schedular
• 100% calibration schedular
• Zero Safety Incidents

📌 Senior Officer (Indore)
🏢 Rubicon Research
📍 Indore