Senior Mechanical Engineer
2 weeks ago
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, ₹60,000.00 per month
Benefits:
- Food provided
- Health insurance
- Provident Fund
Work Location: In person
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