Supervisor
Rubicon Research Limited
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
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
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
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
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
Coordinate with QA and Validation teams to ensure compliance with validated state requirements.
- Continuous Improvement
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