Supervisor

Rubicon Research Limited; Indore District; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Rubicon Research Limited, based in Pithampur, seeks an experienced Supervisor – Manufacturing Maintenance, Engineering to oversee maintenance of OSD manufacturing and packaging equipment. The role involves preventive and breakdown maintenance, calibration, and active involvement in QMS documentation aligned with cGMP requirements.

You will work under the Manager, Engineering in the Engineering/Technical services department, ensuring high equipment availability and compliance across processes.

Qualifications

• Bachelor’s degree in Electrical/Mechanical/Instrumentation is mandatory.
• Strong knowledge of cGMP and regulatory requirements is expected.
• Experience with calibration, validation and engineering drawings is preferred.

Responsibilities

• Perform operation, preventive, and breakdown maintenance of manufacturing process equipment.
• Ensure calibration and maintenance are documented; maintain MTBF and MTTR records.
• Support changes, upgrades, and retrofits per change controls.
• Coordinate with QA, Validation, and EHS teams for regulatory audits.

Skills

OSD equipment systems

cGMP knowledge

Calibration exposure

Validation exposure

Documentation mindset

Audit coordination

Engineering drawings

Regulatory audits exposure

Education

Bachelor’s degree in Electrical/Mechanical/Instrumentation

Tools

QMS software

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

Supervisor – Manufacturing Maintenance, Engineering

Department

Engineering/Technical services

Reporting To

Manager, Engineering

Location

Pithampur

Years Of Experience

05–08 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 Notes

Skills & 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