Maintenance Engineer

Maintenance Engineer
Chantilly, Virginia
Full Time
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
• Maintain and troubleshoot 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 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

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

Core Competencies

• Troubleshooting and technical expertise
• Attention to detail and compliance focus
• Team collaboration and communication
• Continuous improvement mindset
• Time management and reliability

Education

• Bachelor's Degree in Engineering or related field (Required)

Recruiter Submission Template:


Full Name:
Degree Major with University and Completion Year:
Years of Pharmaceutical OSD Maintenance Experience:
Experience with OSD Equipment (Blenders, Granulators, Tablet Press, Coating, Packaging - Details):
Experience with IQ/OQ/PQ Validation (Details):
Troubleshooting Experience (Mechanical/Electrical/Pneumatic/Automation - Details):
Experience with CMMS Systems (Details):
Experience with cGMP / FDA Compliance (Details):
Automation Experience (PLC/HMI/SCADA - Y/N & Details):
Utility Systems Experience (HVAC / Compressed Air - Details):
Motivation / Reason for Relocation (if not local):
Motivation / Reason for interest in this position:
Contact Number:
Email ID:
LinkedIn Profile URL:
Full Address (Street, City, State, Zip Code):
Notice Period (in weeks):
Current Work Authorization Status:
Expected Salary:
Are you able to relocate on your own expenses and work in Chantilly, Virginia?