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.