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

Solid 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

📌 Supervisor (Indore)
🏢 Rubicon Research
📍 Indore