Senior Mechanical Engineer - Pharma Industry

Job Purpose:

To ensure the uninterrupted and compliant operation of mechanical systems and utilities in a pharmaceutical manufacturing facility by leading maintenance activities, ensuring adherence to GMP regulations, and supporting continuous improvement and reliability initiatives.

ey Responsibilities:1. Mechanical Maintenance (GMP Equipment & Utilities):

• Oversee preventive, predictive, and breakdown maintenance of mechanical systems including:
• HVAC systems (AHUs, Chillers, Ducting)
• Compressors, Boilers, Pumps, and Water Systems (PW, WFI)
• Process equipment: Granulators, Coating Machines, Blenders, Compressors, Tablet Presses, etc.
• Cleanroom equipment and containment systems
• Ensure equipment operates within required parameters and meets GMP compliance.

2. Pharmaceutical Compliance:

• Ensure all maintenance activities are compliant with:
• cGMP, USFDA, MHRA, WHO, and other regulatory bodies.
• Maintain and review maintenance documentation including:
• SOPs, Logbooks, Equipment Qualification (IQ/OQ/PQ), and change controls.
• Participate in audits (internal/external) and ensure timely closure of audit observations (CAPA implementation).

3. Team Management:

• Lead and mentor a team of junior engineers and technicians.
• Prepare training plans for maintenance staff regarding GMP, safety, and equipment handling.

4. Reliability & Continuous Improvement:

• Monitor equipment performance using KPIs (MTBF, MTTR, OEE).
• Implement root cause analysis (RCA), failure mode and effect analysis (FMEA) for repeated failures.
• Recommend and implement engineering improvements for reliability and energy efficiency.

5. Vendor & Spare Management:

• Coordinate with vendors for AMC, spares, and breakdown support.
• Review and optimize spare parts inventory for critical equipment.

6. Safety, Health, and Environment (SHE):

• Ensure maintenance activities follow site safety protocols and legal compliance.
• Promote 5S and TPM (Total Productive Maintenance) practices within the department.

Qualifications:

• Education: B.E. / B.Tech in Mechanical Engineering or equivalent.
• Experience: 10 to 15 years of relevant experience in pharmaceutical manufacturing (mandatory), especially in sterile, oral solid dosage, or API environments.

Key Competencies:

• In-depth knowledge of GMP and regulatory guidelines.
• Strong understanding of pharma utilities and mechanical systems.
• Proficient in CMMS software (SAP, Maximo, etc.).
• Good communication and leadership skills.
• Hands-on experience in facing regulatory audits.
• Problem-solving and analytical thinking.

Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹60,000.00 per month

Benefits:

• Food provided
• Health insurance
• Provident Fund

Work Location: In person