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 Associate 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.

Specific Duties, Activities, and Responsibilities

• Partners with other engineers and operations to provide on the floor and technical support for process and equipment issues in the GMP manufacturing areas.
• Authors, reviews and approves technical and manufacturing documentation such as Batch Records, Standard Operating Procedures, Protocols and Technical Reports.
• Participates in the investigation of events and deviations.
• Supports the implementation of Change Controls and Corrective and Preventive Actions (CAPA).
• Collaborates in commercial manufacturing scale-up efforts, development runs and improvement initiatives.
• Supports the execution of commissioning, qualification, validation, and technology transfer activities.
• Serves as a point of contact for the manufacturing lines and equipment and supports the maintenance and calibration.
• Collaborate, communicate, and suggest direction to partners.
• Participates in Continued Process Verification (CPV) meetings and data trending.
• Design and executes detailed experimental protocols, project plans and reports.
• All other duties as assigned

Education and Experience

• B.S. or M.S. degree in a technical discipline (Engineering or Life Sciences preferred)
• 2+ years of relevant experience in technical services or operations support in a pharmaceutical setting or current Good Manufacturing Practices (cGMP) regulated environment
• Demonstrated aptitude for ‘hands-on’ experimentation with an exemplary history as a “self-starter”
• Strong technical problem-solving/troubleshooting skills
• Ability to interpret data and summarize results
• Must be detail oriented with excellent communication and documentation skills
• Ability to work and communicate effectively within a cross-functional team and across levels within an organization.
• Familiarity with one or more Six Sigma/Process Excellence Tools including DoE, process capability analysis, fish bone diagrams, etc. preferred
• Experience with quality systems (CAPAs, change control, deviation management) is a plus

Knowledge, Skills and Abilities

• Demonstrated aptitude for ‘hands-on’ experimentation with an exemplary history as a “self-starter”
• Strong technical problem-solving/troubleshooting skills
• Ability to interpret data and summarize results
• Must be detail oriented with excellent communication and documentation skills
• Ability to work and communicate effectively within a cross-functional team and across levels within an organization.
• Familiarity with one or more Six Sigma/Process Excellence Tools including DoE, process capability analysis, fish bone diagrams, etc. preferred
• Experience with quality systems (CAPAs, change control, deviation management) is a plus

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.