Job Description

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.

Job Summary

The Manufacturing Support Engineer works within cross-functional teams to support internal manufacturing operations. Provides technical support to the engineering of novel particles for drug delivery during bulk manufacturing as well as manages manufacturing deviations and CAPA's.

This role is for a 2,2,3 schedule 12-hour shift support - day shift or night shift will be accepted

Job Requirements

Education and Experience

• BS/MS in a technical discipline (Engineering or Life Sciences preferred)
• 0-2 years (Associate MFG Support Engineer); 2-4 (Sr Associate MFG Support Engineer) 4-8 (MFG Support Engineer); 8+ years (Sr MFG Support Engineer) relevant experience in technical services, operations support or manufacturing sciences in a pharmaceutical setting or current Good Manufacturing Practices (cGMP) regulated environment.

Knowledge, Skills and Abilities

• Strong technical problem-solving and hands on troubleshooting skills.
• 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.

Job Responsibilities

• Support manufacturing operations providing on-the-floor troubleshooting and technical support for process and equipment issues.
• Own equipment or systems supporting manufacturing operations.
• Collaborate, communicate, and suggest direction to internal partners.
• Own and/or support Deviations, Investigations and Corrective and Preventive Actions (CAPA).
• Identify and implement improvement projects.
• Author, review and approve technical, process and manufacturing documentation such as Batch Records and Standard Operating Procedures.
• Support commissioning, qualification, validation, and technology transfer activities.
• Work with cross-functional teams to manufacture materials for clinical and commercial projects.
• All other duties as assigned

Job 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.