Sr. Quality Engineer

Liquidia

About The Position

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 quality representative responsible for providing quality oversight and guidance across validation, facilities, utilities, equipment, analytical instruments, computerized systems, 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 Senior QE provides oversight for validating and maintaining computerized systems for QC analytical instruments, software as a service (SaaS), and manufacturing equipment (PLC and COTs). The Senior QE collaborates cross-functionally with Quality Control, Engineering, Facilities, Manufacturing, and Validation to ensure equipment and systems are designed, maintained, and operated in a state of control consistent with regulatory expectations. Education and Experience Bachelor’s degree in Engineering, Life Sciences, or a related technical field required; advanced degree preferred. 4 - 10 years of experience in Quality Engineering, or QA roles supporting Validation of Analytical Instruments, Computerized Systems, Equipment, Facilities, and Utilities in the pharmaceutical and biotechnology. Strong understanding of GMP regulations (FDA, EMA, ICH, ISPE guidelines) related to validation, automation, equipment, utilities, calibration, and maintenance. Experience with cleaning validation and quality risk management practices. Knowledge Skills and Abilities

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical field required; advanced degree preferred.
4 - 10 years of experience in Quality Engineering, or QA roles supporting Validation of Analytical Instruments, Computerized Systems, Equipment, Facilities, and Utilities in the pharmaceutical and biotechnology.
Strong understanding of GMP regulations (FDA, EMA, ICH, ISPE guidelines) related to validation, automation, equipment, utilities, calibration, and maintenance.
Experience with cleaning validation and quality risk management practices.
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.

Responsibilities

Provide quality oversight for the design, qualification, validation, and maintenance of GMP-critical systems including QC analytical instruments, facilities, HVAC, clean utilities, and manufacturing equipment.
Provide quality oversight for computerized systems and manufacturing equipment (PLC, COTS, and SaaS systems) used in 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 for QC analytical instruments.
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 QC analytical instruments.
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.