Process Equipment Engineer- Oral Solid Dosage experience required

Smart Media; Chantilly (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

Smart Media is seeking a skilled Pharmaceutical Process Equipment Engineer in Chantilly, VA to ensure reliability and compliance of manufacturing equipment and facility systems for safe, efficient production.

The role focuses on maintenance, qualification (IQ/OQ), and continuous improvement of tablet presses, granulators, coating and packaging lines, with strong collaboration across Production, Quality, and Engineering teams.

Qualifications

• Bachelor's degree in engineering (Mechanical, Electrical, Industrial) or related field.
• 4+ years of maintenance experience in a pharmaceutical oral solid dosage environment.
• Strong knowledge of cGMP, FDA regulations and safety.
• Hands-on with tablet compression, encapsulation, granulation, and coating equipment.
• Ability to read mechanical drawings and electrical schematics.
• Experience with CMMS systems and maintenance documentation.
• Strong troubleshooting and problem-solving skills.
• Ability to work independently and in cross-functional teams.

Responsibilities

• Perform preventive, predictive, and corrective maintenance on solid oral dosage equipment.
• Troubleshoot mechanical, electrical, pneumatic, and automation issues to minimize downtime.
• Support equipment installation, commissioning, IQ/OQ, and validation activities.
• Maintain 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 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.

Skills

Troubleshooting

Documentation

Independent work

Education

Bachelor’s degree in Mechanical, Electrical, Industrial, or related Engineering field

Tools

CMMS

Job description

Description

We are seeking a skilled and proactive Pharmaceutical Process Equipment 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.
  
  
  • 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.

Requirements

Minimum 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, 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

We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.