Maintenance Engineer
Job Description
Role : Maintenance Engineer
Experience: 4 - 15 Years
Domain : Pharmaceuticals/Biotechnology/Clinical Research
Location: Chantilly, USA
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
Minimum 4 years of maintenance experience specifically in a pharmaceutical OSD (oral solid dosage) manufacturing environment. Also okay if Pharma, biotech, and life science industries.
Experience supporting IQ/OQ/PQ qualification and validation activities.
Ability to troubleshoot across mechanical, electrical, pneumatic, and automation systems.
Proficiency in reading mechanical drawings, electrical schematics, and equipment manuals.
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.