Perform preventive, predictive, and breakdown maintenance of sterile manufacturing equipment such as reactors, centrifuges, autoclaves, sterilizers, isolators, and filtration systems.
Maintain and troubleshoot cleanroom utilities including HVAC systems, AHUs, LAF units, chillers, boilers, purified water systems, and compressed air systems.
Ensure equipment operates within validated parameters and complies with GMP and regulatory standards.
Execute and document maintenance activities in accordance with SOPs and documentation practices (GDP).
Support qualification and validation activities (IQ, OQ, PQ) for equipment and utilities.
Coordinate with production and QA teams to ensure minimal disruption to sterile operations.
Participate in root cause analysis (RCA) for equipment failures and implement corrective and preventive actions (CAPA).
Ensure adherence to safety procedures, including handling of hazardous materials and working in classified areas.
Maintain spare parts inventory and coordinate with vendors for repairs and servicing.
Assist during audits and inspections by regulatory authorities.
Required Qualifications:
Diploma / Bachelor's Degree in Mechanical, Electrical, or Instrumentation Engineering (or related field).
2–8 years of experience in pharmaceutical API sterile or regulated manufacturing environments.
Hands-on experience with sterile equipment and cleanroom maintenance.
