Maintenance Technician - Pharmaceutical Manufacturing

Job Description

Job Description

Position Summary

This role focuses on equipment uptime, preventive maintenance, troubleshooting, and continuous improvement of utilities and process equipment—including tablet presses, granulation systems, and HVAC systems supporting cleanroom operations.

Key Responsibilities

• Perform and oversee preventive, predictive, and corrective maintenance on pharmaceutical manufacturing and facility equipment.
• Lead troubleshooting and repair efforts on tablet presses, granulators, blenders, fluid bed dryers, coating machines , and other process equipment.
• Maintain and repair facility utilities such as HVAC systems, compressed air, purified water, steam, chilled water, and vacuum systems .
• Support calibration and mechanical integrity programs to ensure GMP compliance.
• Collaborate with Production, Engineering, and Quality departments to minimize downtime and ensure regulatory requirements are met.
• Review and update maintenance SOPs, work orders, and documentation in accordance with cGMP and FDA standards.
• Train and mentor junior technicians and provide technical guidance during shifts or project work.
• Participate in capital projects, equipment installation, and commissioning/qualification activities (IQ/OQ/PQ).
• Identify and implement process improvements to increase reliability and reduce maintenance costs.
• Support environmental monitoring and cleanroom operation standards through proper maintenance of HVAC and filtration systems.

Qualifications

• Education: Associate’s or Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering (or equivalent technical discipline) preferred.
• Experience: Minimum 5–8 years in a maintenance or engineering role within a pharmaceutical, biotech, or GMP manufacturing environment.
• Strong hands-on experience with tablet compression, granulation, and packaging equipment .
• Working knowledge of HVAC systems , cleanroom environments, and associated regulatory requirements (ISO 14644, cGMP).
• Familiarity with CMMS systems (e.g.,, BMRAM, Maximo, SAP PM) and maintenance documentation practices.
• Strong understanding of electrical, mechanical, and pneumatic systems.
• Excellent problem-solving, communication, and leadership skills.

Preferred Skills

• Knowledge of PLCs and control systems troubleshooting.
• Experience with aseptic or sterile manufacturing utilities.
• Understanding of 21 CFR Part 11 and data integrity principles.
• Root cause analysis and reliability-centered maintenance experience.