Process 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 arterial hypertension (PAH). 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 Process Engineer / Deviation Owner is responsible for leading cross-functional engineering projects while also serving as a technical lead and deviation owner for manufacturing and quality events. Provides technical support to resolve complex process and equipment issues, investigate deviations as well as leading process changes and projects to drive continuous improvement. Manages equipment onboarding, technology transfers and process performance qualification strategy to support the engineering of novel particles for drug delivery during bulk manufacturing.

• 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

• 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

Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off 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.

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.