Lead Maintenance Specialist

Liquidia Corporation; Morrisville (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

STD

LTD

401(k) Savings Retirement Plan

ESPP

Job summary

Liquidia Corporation in Morrisville, NC is seeking a Maintenance Specialist to ensure reliability, compliance, and lifecycle management of manufacturing equipment, facilities, and utility systems in a GMP pharmaceutical environment.

You will partner with Engineering, Validation, Manufacturing, Quality, Facilities and external vendors to ensure assets are properly commissioned, enrolled, maintained, and operated according to GMP and regulatory standards, while driving continuous improvement.

Qualifications

• 8+ years of relevant experience in pharmaceutical facilities or equipment maintenance.
• Experience with CMMS platforms (Maximo, SAP PM, Oracle, etc.).
• Knowledge of CQV, GMP regulations, and FDA Part 11 is preferred.

Responsibilities

• Review turnover packages to ensure maintenance readiness before asset acceptance.
• Coordinate asset induction and enrollment into CMMS; support commissioning and qualification.
• Maintain and improve preventive maintenance programs to maximize reliability.
• Support vendor maintenance activities and ensure safety and GMP compliance.
• Prepare and review maintenance documentation and participate in audits.

Skills

Maintenance planning

Project management

Analytical troubleshooting

Regulatory awareness

Education

Bachelor's degree in Engineering or related

High School diploma + 12+ years experience

Tools

Maximo

SAP PM

Oracle

Blue Mountain

Job description

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.

Job responsibilities

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
• 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
• WFI systems
• Purified Water
• Clean Steam
• Compressed Air
• Boilers
• 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.
• 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.

Job requirements

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.
• 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.

Liquidia offers a competitive compensation package as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, and more!

• Medical
• Dental
• Vision
• STD
• LTD
• 401(k) Savings Retirement Plan
• ESPP
• and more!

Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.