SENIOR PROCESS ENGINEER Liquidia Technologies
Liquidia Technologies, founded in 2004, is a privately held biotechnology company located in Research Triangle Park, North Carolina. By leveraging precise fabrication techniques of the semiconductor industry, Liquidia has become the only company in the world with the ability to rapidly design and manufacture precisely engineered particles of virtually any size, shape or composition using a unique particle engineering and manufacturing technology known as the PRINT (Particle Replication In Non-Wetting Templates) platform. In addition to the development of its own products, Liquidia licenses the PRINT particle technology and its cGMP manufacturing capabilities to support proprietary programs advanced by collaborators. For more information, please go to www.liquidia.com.
In 2013, Liquidia Technologies formed a new company, Envisia Therapeutics?, to develop novel therapeutics that can address critical unmet needs in ophthalmology. To address these critical unmet needs, Envisia is using the proprietary PRINT technology platform to rationally design and manufacture micro- and nano-particle systems. These particles, which can incorporate either small molecule or biologic therapeutics, are designed and manufactured with the goal of improving the delivery, safety and efficacy of ocular medications. For more information, please go to www.envisiatherapeutics.com
Envisia and Liquidia are independent companies with distinct areas of focus, dedicated teams and independent funding. Initially, Neal Fowler and his executive team will lead both Envisia and Liquidia.
The Process Engineer role will be responsible for ensuring that Liquidia?s manufacturing facilities, equipment and processes comply with current Good Manufacturing Practices (cGMPs) as projects transition from R&D to product development. The primary function is to oversee the development, implementation and maintaining of key processes and controls to ensure product quality as well as compliance with FDA and other regulatory agency requirements. This role will be responsible for all aspects of SOP writing, protocol execution, change control evaluation, and routine documentation. This position will also be responsible for assisting R&D teams in process development activities to ensure manufacturing processes meet all critical quality attributes (CQAs) in a repeatable and predictable manner.
Implement and maintain cGMPs for pilot scale manufacturing areas
Design and execute qualification activities for key manufacturing and facility systems including IQ/OQ/PQ, maintenance and monitoring procedures and cleaning procedures
Utilize a Quality By Design (QBD) approach to process development while leading efforts in the transition from lab scale to pilot scale manufacturing
Work with a team of engineers and technicians to manufacture materials to support preclinical and clinical R&D projects
Support R&D project teams through the use of process engineering tools such as root cause analysis, risk assessment and Six Sigma tools
Serve as lead manufacturing representative for one or more R&D project teams to develop process capabilities to ensure adequate material supplies to meet project objectives
Lead small to medium scope projects including the evaluation and implementation of process changes to improve product quality, decrease cost, and improve manufacturing efficiencies
Maintain accurate, detailed documentation throughout all phases of process development
BS/MS in a technical discipline (Engineering preferred)
5+ years of experience in process development or manufacturing operations in Medical Device, Pharmaceutical or other FDA regulated industry required
Thorough understanding and experience in equipment qualification, risk-based validation and cGMP systems implementation
Experience with sterile dosage forms a plus
Demonstrated aptitude for ?hands-on? experimentation with an exemplary history as a ?self-starter?
Knowledge of Six Sigma/Process Excellence Tools including DoE, process capability analysis, C/E Matrix, pFMEA, fish bone diagrams, etc
Mechanical aptitude is a must, experience in the troubleshooting of production equipment preferred
Demonstrated experience in DOE including experimental design, execution, data analysis and results summation
Ability to summarize data and results for business and technical audiences
Ability to work as part of a cross functional team with manufacturing, research and development, analytical and biology staff
||P.O. Box 110085 |
Research Triangle Park, NC 27709