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.
Numbers & Facts
Location
Chantilly, VA
Skills
Automationunmatched
Automation Systemsunmatched
Biotech and Pharmaceuticalunmatched
Capsulesunmatched
Commissioningunmatched
Computerized Maintenance Management System (CMMS)unmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
Electrical Componentsunmatched
Electricityunmatched
FDA Requirementsunmatched
HVACunmatched
Human Machine Interface (HMI)unmatched
Identify Issuesunmatched
Inventory Managementunmatched
Lean Manufacturingunmatched
Manufacturingunmatched
Manufacturing Equipmentunmatched
Process Engineeringunmatched
Process Improvementunmatched
Process Validationunmatched
Programmable Logic Controller (PLC)unmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Record Keepingunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Reliability Engineeringunmatched
Root Cause Analysisunmatched
Safety Complianceunmatched
Schematicsunmatched
Supervisory Control and Data Acquisition (SCADA)unmatched
Systems Maintenanceunmatched
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