Senior Mechanical Engineer

1 week ago

Hyderabad, India Pardha Constrcution Full time

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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