Senior Quality Engineer

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.

Job Summary

The Senior Quality Engineer is a senior technical leader responsible for providing quality oversight and guidance across validation, facilities, utilities, equipment, maintenance, and calibration programs in a GMP-regulated environment. This role ensures compliance with applicable regulations, supports risk-based decision-making, and drives continuous improvement in the qualification, validation, and lifecycle management of GMP assets. The Principal QE provides oversight for validating and maintaining automated equipment (PLC and COTS) used in manufacturing operations. The Principal QE collaborates cross-functionally with Engineering, Facilities, Manufacturing, and Validation to ensure equipment and systems are designed, maintained, and operated in a state of control consistent with regulatory expectations.

Responsibilities

• Provide quality oversight for the design, qualification, validation, and maintenance of GMP-critical systems including facilities, HVAC, clean utilities, and manufacturing equipment.
• Provide quality oversight for automated equipment (PLC and COTS systems) used in manufacturing operations.
• Serve as QA approver for P&ID drawings, protocols, reports, change controls, deviations, and investigations related to equipment and facility systems.
• Participate in cross-functional project teams to support new equipment implementation, engineering changes, and capital projects.
• Review and approve calibration and preventive maintenance plans to ensure GMP compliance and data integrity.
• Perform quality impact assessments for unplanned maintenance, calibration out-of-tolerance (OOT) events, and equipment failures.
• Lead or support quality investigations, root cause analysis, and CAPA related to equipment and utility issues.
• Support internal and external audits and regulatory inspections as a subject matter expert (SME) for quality engineering topics.
• Collaborate with Engineering and Validation teams to ensure risk-based approaches are applied to qualification activities (e.g., leveraging ASTM E2500, ICH Q9).
• Drive continuous improvement in equipment lifecycle management, maintenance systems, and quality processes.
• Provide mentorship and technical guidance to junior QA staff.

Requirements

Education and Experience

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field required; advanced degree preferred.
• 8+ years of experience in Quality Engineering, or QA roles supporting Validation, Facilities, and Engineering QA in the pharmaceutical, biotechnology, or medical device industry.
• Strong understanding of GMP regulations (FDA, EMA, ICH, ISPE guidelines) related to validation, automation, equipment, utilities, calibration, and maintenance.
• Experience with facility and utility qualification, equipment validation, cleaning validation, and quality risk management practices.

Knowledge, Skills, and Abilities

• Expert knowledge of cGMP requirements related to facilities, equipment, and utilities in a pharmaceutical or biotech environment.
• Knowledge of engineering standards and validation lifecycle (URS, DQ, IQ, OQ, PQ).
• Strong analytical and critical thinking skills; able to evaluate complex systems and data.
• Excellent technical writing and documentation review skills.
• Demonstrated ability to collaborate and influence cross-functional teams.
• Proficiency in quality systems (e.g., Veeva) and computerized maintenance management systems (CMMS).
• Strong project management and organizational skills with attention to detail.

Benefits

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!

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.

Recruiting Agencies, Please Note:

Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.