Mechanical Engineer: Formulation (OSD & Oral Liquid)

Role & responsibilities

1. Equipment Maintenance & Troubleshooting

• Hands-on experience in troubleshooting mechanical issues related to Oral Solid Dosage (OSD) equipment (tablet, capsule machinery) and Oral Liquid manufacturing equipment.
• Responsible for timely rectification of breakdowns to avoid production loss and ensure minimum equipment downtime.
• Conduct Root Cause Analysis (RCA) for repeated problems and implement corrective and preventive actions.
• Experience in installation, commissioning, and mechanical maintenance of machinery such as Blister Packaging Machines, Capsule Filling Machines, and Dry Syrup lines.
• Handle maintenance of utility equipment such as boilers, chillers, compressors, hot water systems, and purified water systems (PWS).
• Oversee operation and maintenance of process equipment including reactors, centrifuges, VTD, RCVD, Multifil, blenders, ball mills, shifters, FBC, and FBD.

2. Preventive Maintenance & Planning

• Plan and execute preventive maintenance activities for all facility and process equipment.
• Ensure spares management by monitoring inventory and maintaining availability to minimize downtime.
• Coordinate with external agencies for calibration, maintenance activities, and AMCs (Annual Maintenance Contracts).

3. Compliance, Documentation & Audits

• Ensure adherence to cGMP regulations, Good Engineering Practices (GEP), safety guidelines, and regulatory norms.
• Maintain and manage engineering documentation, SOPs, qualification documents (DQ, IQ, OQ, PQ), and other engineering-related records.
• Actively participate in closure of QMS elements such as CCP, CAPA, deviations, and risk assessments.
• Assist in ensuring compliance during internal, external, and ISO audits.
• Conduct HIRA and Aspect-Impact studies as part of EHS compliance.
• Maintain readiness for regulatory inspections and audits at all times.

4. Coordination & Team Management

• Work closely with production, process, quality, and safety teams to support operational requirements.
• Allocate work and supervise a team of technicians (fitters and electricians) to ensure smooth execution of engineering tasks.
• Monitor daily operations of mechanical processes across all equipment and utilities.
• Prepare daily engineering reports, MORs, and maintenance records.

5. Budgeting & Reporting

• Prepare annual Capex and Opex budgets for the engineering department and ensure effective control and monitoring.
• Prepare and review daily, weekly, and monthly reports on maintenance activities, breakdowns, and equipment performance.

6. Validation & Qualification

• Support HVAC validation, water system validation, and periodic equipment qualification/requalification.
• Ensure process maintenance activities comply with engineering documentation, qualification requirements, and audit expectations.

Note:

Years of Experience:

5+ years

Preferred candidate profile

Qualification:

B.E. in Mechanical Engineering