Senior Officer

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

• Strong 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

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