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

- 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

📌 Senior Officer (Indore)
🏢 Rubicon Research
📍 Indore