Validation & Maintenance Engineer

Summary

The Maintenance Engineer will be responsible for ensuring the reliability, performance, and compliance of pharmaceutical manufacturing equipment within an Oral Solid Dosage (OSD) environment. This role involves hands-on maintenance, troubleshooting, validation support, and continuous improvement of production equipment to ensure safe and efficient operations.

Key Responsibilities

• Perform preventive, predictive, and corrective maintenance on OSD manufacturing equipment
• Troubleshoot mechanical, electrical, pneumatic, and automation systems
• Support installation, commissioning, IQ/OQ/PQ qualification, and validation activities
• Maintain accurate records in CMMS systems (work orders, logs, maintenance history)
• Ensure compliance with cGMP, FDA, and safety regulations
• Collaborate with Production, Quality, and Engineering teams
• Conduct Root Cause Analysis (RCA) and implement CAPA
• Support audits, inspections, and regulatory documentation
• Manage spare parts inventory and equipment reliability initiatives
• Identify opportunities for process improvement and equipment upgrades

Maintain and troubleshoot equipment including:

• Blenders, granulators, mills
• Fluid bed coaters
• Tablet presses and capsule fillers
• Coating machines
• Packaging lines (bottle, blister, cartoners)

Must-Have Requirements

• Bachelor’s degree in Mechanical, Electrical, Industrial Engineering or related field (or equivalent experience)
• 4+ years of maintenance experience in pharmaceutical OSD manufacturing (mandatory)
• Strong hands-on experience with OSD equipment (blenders, granulators, tablet presses, coating, packaging lines)
• Experience supporting IQ/OQ/PQ validation activities
• Ability to troubleshoot across mechanical, electrical, pneumatic, and automation systems
• Ability to read mechanical drawings, electrical schematics, and manuals

Required Skills

• Strong knowledge of cGMP and FDA regulations
• Hands-on troubleshooting and maintenance expertise
• Experience with CMMS systems and documentation
• Strong analytical and problem-solving skills
• Ability to work independently and in cross-functional teams
• Strong communication and documentation skills

Preferred / Nice-to-Have Skills

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