Senior Officer

Rubicon Research Limited; Indore; On-site; INR 600,000 - 900,000; Full time

Job summary

Rubicon Research Limited in Pithampur seeks an Sr. Officer – Manufacturing Maintenance, Engineering to oversee operation, maintenance, calibration, and QMS documentation for Electrical/Mechanical/Instrumentation systems across OSD manufacturing and packaging areas.

You will drive preventive and breakdown maintenance, support calibration and validation activities, and ensure regulatory compliance per USFDA/EU-GMP/WHO guidelines, collaborating with QA, Validation, and EHS teams.

Qualifications

• Bachelor’s degree in Electrical/Mechanical/Instrumentation (mandatory).
• Strong understanding of OSD manufacturing equipment systems and GMP compliance.
• Exposure to calibration, validation, and QA/audit processes.
• Ability to read P&ID and electrical drawings; good documentation practices.
• Experience coordinating with Production, QA, Validation and EHS teams.

Responsibilities

• Perform preventive, breakdown, and calibration maintenance on manufacturing process equipment.
• Maintain MTBF/MTTR reports and ensure minimum downtime.
• Support change controls, deviations, CAPA, and QMS documentation.
• Coordinate IQ/OQ/PQ qualification activities for equipment and systems.
• Assist regulatory audits and inspections with technical inputs and documentation.
• Drive continuous improvement in equipment reliability and energy efficiency.

Skills

OSD equipment knowledge

cGMP knowledge

Calibration exposure

Validation exposure

Documentation & audit readiness

Cross-functional coordination

Reading engineering drawings

Regulatory audits exposure

Education

Bachelor's degree in Electrical/Mechanical/Instrumentation

Job description

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:

• Granulation lines (RMG, FBD, Mill, Blender)
• Dispensing units and material handling systems
• Coating machines (Auto coaters)
• Compression machines
• Track & Trace systems
• Primary packaging areas (Blister, Strip, Bottle lines etc.)
• Secondary 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:
  • Change Control (CC)
  • Deviation and incident handling
  • CAPA 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