Maintenance Engineer

Role : Maintenance Engineer

Experience: 4 - 15 Years

Domain : Pharmaceuticals/Biotechnology/Clinical Research

Location: Chantilly, USA

About the Role: We are seeking a skilled and proactiveMaintenance Engineerwith experience in theoral 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.