Senior 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 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 Process Engineer works within cross-functional teams to support internal and external manufacturing of operations. Provides technical support to the engineering of novel particles for drug delivery during bulk powder manufacturing as well as downstream encapsulation, blistering and packaging.

Job Responsibilities

• Lead Investigator for major process deviations, critical equipment failures and quality events in a cGMP manufacturing environment.
• Lead Root Cause Analysis partnering with a cross-functional team and track progress of investigational activities ensuring timely resolution.
• Authors and reviews deviation reports, developing Corrective and Preventive Actions (CAPA) plans as well as their implementation.
• Understands the manufacturing processes and provides technical support for process and equipment issues.
• Supports regulatory inspections and internal audits.
• Supports scale-up of commercial manufacturing and implementation of process changes and improvement projects.
• Support commissioning, qualification, validation, and technology transfer activities.
• Collaborate, communicate, and suggest direction to external and internal partners.
• Author, review and approve technical and manufacturing documentation such as Batch Records, Standard Operating Procedures, Protocols and Technical Reports.
• Analyze historical data and trends to identify issues. Supports Statistical Data Analysis for Continued Process Verification (CPV)
• Work with team of engineers and technicians to manufacture materials for clinical and commercial projects.
• Design and executes detailed experimental protocols, project plans and reports.
• All other duties as assigned

Job Requirements

Education and Experience

• BS/MS in a technical discipline (Engineering or Life Sciences preferred)
• 7 years relevant experience in technical services, operations support or manufacturing sciences in a pharmaceutical setting or current Good Manufacturing Practices (cGMP) regulated environment.
• Proven experience leading investigations and resolving complex process issues or quality events.

Knowledge, Skills and Abilities

• Strong technical problem-solving/troubleshooting skills
• Excellent technical writing and documentation skills.
• Experience with project strategic plan, development, and management
• Experience with encapsulation, blistering and packaging for inhalation products
• Working knowledge of quality management system elements, including change control, deviation management, and corrective and preventive actions.
• Ability to work and communicate effectively within a cross-functional team and across levels within an organization.
• Demonstrated ability to work independently and as part of a team
• 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
• Mechanical aptitude for troubleshooting of production equipment, including automated systems preferred.
• Knowledge of FDA cGMP regulations

Benefits

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.

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.