Liquidia Corporation · 11 hours ago
Process Engineer
Morrisville, NC
Full-time
Onsite
Mid, Senior Level
2+ years expLiquidia Corporation is dedicated to the discovery and development of novel therapies for patients with pulmonary arterial hypertension. The Process Engineer will lead cross-functional engineering projects, serve as a technical lead, and manage deviations and process changes to drive continuous improvement in manufacturing operations.
BiotechnologyIndustrialHealthcarePharmaceuticalBiopharmaHealth CareNanotechnologyTherapeutics
Hiring Manager
Brian Duggan
Responsibilities
Own and manage process changes, engineering projects and continuous improvement initiatives from initiation through implementation and closing
Author and execute change controls, deviation responses and impact assessments as required
Lead investigation and conduct root cause analysis for major deviations and non-conformances. Drives improvement to the investigation process
Collect and analyze relevant data to support investigations objectively
Ensure stakeholders are informed of the progress of the investigation process and projects
Author detailed investigation reports
Develop and implement corrective and preventive actions (CAPA)
Perform process data trending and statistical Data Analysis for Continued Process Verification (CPV)
Serve as technical lead for Technology Transfers and strategy for process performance qualifications (PPQ)
Present, defend and support change controls and investigations during regulatory inspections
Onboard and troubleshoot equipment
Author, review and approve technical, process and manufacturing documentation such as Batch Records, Standard Operating Procedures, Protocols and Technical Reports
Train and mentor other process engineers
All other duties as assigned
Qualification
Required
BS/MS in Engineering or Life Science
Experience leading complex investigations and projects
2-4 (Sr Associate Process Engineer); 4-8 (Process Engineer); years of relevant technical experience (operations support, quality assurance or manufacturing sciences) in a pharmaceutical setting or current Good Manufacturing Practices (cGMP) regulated environment
Proficient knowledge of deviation management, root cause analysis and CAPA processes
Strong problem-solving and analytical skills
Experience in statistical analysis, risk assessment and quality reporting
Working knowledge of quality management systems, including change control, deviation management, and corrective and preventive actions
Excellent communication, project management and presentation skills, working effectively within a cross-functional team and across levels within an organization
Ability to summarize data and results for business and technical audiences
Knowledge of Six Sigma/Process Excellence Tools including DoE process capability analysis, pFMEA, fish bone diagrams, statistical analysis
Knowledge of FDA cGMP regulations
Benefits
Medical
Dental
Vision
STD
LTD
401(k) Savings Retirement Plan
ESPP
Unlimited Paid Time Off
Company
Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company focused on the development and commercialization of products in pulmonary hypertension and other applications of its PRINT® Technology.
51-200 employees
H1B Sponsorship
Liquidia Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$533.4MKey Investors
HealthCare Royalty PartnersCaligan Partners,HealthCare Royalty PartnersPatient Square Capital
2025-06-23Post Ipo Debt· $50M
2024-09-11Post Ipo Equity· $67.5M
2024-01-04Post Ipo Equity· $75M
Leadership Team
Roger Jeffs
Chief Executive Officer
Mike Kaseta
Chief Financial Officer
Recent News
2026-01-07
New Enterprise Associates
2026-01-06
Company data provided by crunchbase