Note: The job is a remote job and is open to candidates in USA. Liquidia is focused on discovering, engineering, and developing novel therapies, particularly for improving the treatment of pulmonary hypertension. The Maintenance Specialist ensures the reliability, compliance, and lifecycle management of manufacturing equipment, facilities, and utility systems in a GMP pharmaceutical manufacturing environment while supporting capital projects, commissioning and qualification, CMMS administration, preventive maintenance, and continuous improvement.
Responsibilities
- 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
- 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
- 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
- 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
- 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
- Participate in Root Cause Analysis (RCA) investigations
- Recommend equipment reliability improvements
- Support predictive maintenance technologies
- Drive continuous improvement initiatives
Skills
- 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
- 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
- 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
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Short-term disability (STD)
- Long-term disability (LTD)
- 401(k) Savings Retirement Plan
- Employee Stock Purchase Plan (ESPP)
Company Overview
Company H1B Sponsorship