Job Description

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