Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

The Maintenance Specialist is responsible for ensuring the reliability, compliance, and lifecycle management of manufacturing equipment, facilities, and utility systems within a GMP pharmaceutical manufacturing environment. This role serves as a technical resource supporting capital projects, commissioning and qualification activities, engineering turnover, asset lifecycle management, computerized maintenance management system (CMMS) administration, preventive maintenance optimization, and continuous improvement initiatives.
The individual partners closely with Engineering, Validation, Manufacturing, Quality, Facilities, and external vendors to ensure all assets are properly commissioned, enrolled, maintained, and operated in compliance with GMP, regulatory, and company standards. Education and Experience:

• B.S. degree in Engineering, Maintenance or related field with 8+ years of relevant experience.
• High School diploma with 12+ years of hands-on experience in pharmaceutical facilities or equipment maintenance.

Preferred Qualifications:

• Experience with CMMS platforms (e.g., Maximo, SAP PM, Oracle, Blue Mountain, or similar).
• Knowledge of Commissioning, Qualification, and Validation (CQV).
• Understanding of GMP regulations and pharmaceutical manufacturing.
• Knowledge of FDA 21 CFR Parts 210, 211, and Part 11.
• Familiarity with ISPE Good Practice Guides.
• Experience with reliability-centered maintenance (RCM).
• Knowledge of predictive maintenance technologies.
• Experience supporting regulatory inspections.

Knowledge, Skills & Abilities:

• Strong understanding of maintenance and reliability principles.
• Knowledge of facilities and utility systems.
• Excellent organizational and project management skills.
• Ability to prioritize multiple competing activities.
• Strong analytical and troubleshooting skills.
• Excellent written and verbal communication.
• Proficiency with Microsoft Office and CMMS software.
• Ability to interpret engineering drawings, P&IDs, equipment manuals, and technical documentation.
• Strong understanding of equipment lifecycle management.
• Working knowledge of risk-based maintenance strategies.
• Strong collaboration and stakeholder management skills.
• Commitment to safety, quality, and continuous improvement.

Engineering Turnover & Asset Lifecycle:

• Review Engineering Turnover Packages (ETOPs) to ensure completeness and maintenance readiness prior to asset acceptance.
• Participate in project design reviews, FAT/SAT activities, commissioning, qualification, and startup support.
• Coordinate asset induction and enrollment into the CMMS.
• Establish equipment hierarchy, asset records, preventive maintenance strategies, spare parts requirements, and maintenance documentation.
• Verify turnover documentation including:
  • Equipment manuals
  • Recommended spare parts
  • Preventive maintenance requirements
  • Calibration requirements
  • Vendor documentation
  • Warranty information
  • Drawings and technical files
• Support successful transition from Capital Projects to Operations.

Maintenance Program Management:

• Maintain, and continuously improve preventive and predictive maintenance programs.
• Review maintenance plans to optimize reliability and equipment availability.
• Ensure all maintenance activities comply with GMP requirements and site procedures.
• Support maintenance planning and scheduling to minimize production interruptions.
• Monitor maintenance KPIs.

Facilities, Utilities & Manufacturing Equipment:
Coordinate maintenance activities supporting:

• HVAC systems
• Clean utilities
• WFI systems
• Purified Water
• Clean Steam
• Compressed Air
• Boilers
• Chillers
• Process gases
• Building Management Systems (BMS)
• Environmental Monitoring support equipment
• Manufacturing equipment
• Packaging equipment
• Laboratory support systems
• General building infrastructure

Ensure equipment remains inspection-ready and compliant with regulatory expectations.

Vendor & Contractor Management:

• Coordinate vendor maintenance activities as needed.
• Review vendor service reports for completeness.
• Ensure contractor work complies with site safety and GMP requirements.
• Support contractor qualification and onboarding.
• Monitor vendor performance and service quality.

Compliance & Documentation:

• Maintain maintenance documentation in accordance with:
  • GMP
  • FDA
  • EU GMP
  • Data Integrity principles
  • Site procedures
• Support internal audits, customer audits, and regulatory inspections.
• Participate in investigations related to equipment failures.
• Support CAPA implementation.
• Review and approve maintenance documentation as appropriate.

Reliability & Continuous Improvement:

• Participate in Root Cause Analysis (RCA) investigations.
• Recommend equipment reliability improvements.
• Support predictive maintenance technologies.
• Drive continuous improvement initiatives.