Pharma Maintenance Engineer

Umanist NA; Chantilly (VA); On-site; USD 70,000 - 90,000; Full time

Job summary

A pharmaceutical company is seeking a skilled Maintenance Engineer to ensure reliable operation and maintenance of manufacturing equipment in a compliant and efficient manner. The ideal candidate will have over 4 years of experience in a solid dosage manufacturing environment and a strong understanding of cGMP and FDA regulations. Responsibilities include performing maintenance, troubleshooting equipment issues, and collaborating with cross-functional teams. This role offers the opportunity to enhance process optimization and equipment reliability in a dynamic setting.

Qualifications

• 4+ years of maintenance experience in a pharmaceutical oral solid dosage manufacturing environment.
• Strong understanding of cGMP, FDA, and safety regulations.
• Hands-on experience with various manufacturing equipment.

Responsibilities

• Perform preventive, predictive, and corrective maintenance on solid oral dosage equipment.
• Troubleshoot mechanical, electrical, pneumatic, and automation issues.
• Collaborate with Production, Quality, and Engineering teams.

Skills

automation

maintenance

CMMS

manufacturing

Education

Bachelor’s degree in mechanical, Electrical, Industrial, or related Engineering

Job description

Job Summary

We are seeking a skilled and proactive Maintenance Engineer with experience in the oral solid dosage (OSD) pharmaceutical industry. The ideal candidate will be responsible for ensuring reliable operation, maintenance, and continuous improvement of manufacturing equipment and facility systems to support safe, compliant, and efficient production.

Key Responsibilities

• Perform preventive, predictive, and corrective maintenance on solid oral dosage equipment, including:
  • Blenders, granulators, mills, Fluid bed coaters.
  • Tablet presses and capsule fillers
  • Coating machines.
  • Packaging lines (bottle, blister, cartoners)
• Troubleshoot mechanical, electrical, pneumatic, and automation issues to minimize downtime.
• Support equipment installation, commissioning, qualification (IQ/OQ), and validation activities.
• Maintain accurate maintenance records, work orders, and equipment logs in the CMMS system.
• Ensure all maintenance activities comply with cGMP, safety, and regulatory requirements.
• Collaborate with Production, Quality, and Engineering teams to resolve equipment-related issues.
• Participate in root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
• Identify opportunities for equipment upgrades, reliability improvements, and process optimization.
• Support audits, inspections, and documentation requests from QA and regulatory bodies.
• Ensure spare parts inventory is maintained and managed effectively.

Qualifications

• Bachelor’s degree in mechanical, Electrical, Industrial, or related Engineering field (or equivalent experience).
• 4+ years of maintenance experience in a pharmaceutical oral solid dosage manufacturing environment.
• Strong understanding of cGMP, FDA, and safety regulations.
• Hands‑on experience with tablet compression, encapsulation, granulation, Fluid bed coaters, and coating equipment.
• Ability to read mechanical drawings, electrical schematics, and equipment manuals.
• Experience with CMMS systems and maintenance documentation.
• Strong troubleshooting, analytical, and problem‑solving skills.
• Ability to work independently and in cross‑functional teams.

Preferred Skills

• Experience with automation systems (PLC, HMI, SCADA).
• Knowledge of HVAC compressed air, and utility systems.
• Familiarity with lean manufacturing and reliability engineering principles.

Skills: automation, maintenance, CMMS, manufacturing