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Job: Sr. Process Engineer, Taylor Strategy Partners, Raleigh, NC
Sr. Process Engineer
Raleigh, NC 27617 United States
8045 Arco Corporate Drive
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 through product development into clinical manufacturing. The primary function is to oversee process development activities to ensure process understanding and robustness as well as compliance with FDA and other regulatory agency requirements. This role is expected to be a hands-on role requiring process experimental design and execution, data analysis and interpretation and summation of process knowledge to support technical reports and regulatory filings. The position will work closely with R&D, Regulatory and Quality Assurance organizations to ensure solid understanding of the processing space and implementation of a sound process control strategy.
Utilize a Quality By Design (QBD) approach to process development while leading efforts in the transition from pilot scale to commercial manufacturing
Design and execution of process experimental designs with the focus of process window definition and process robustness
Implement and maintain critical process controls for each step of the manufacturing process
Design and execute qualification activities for key manufacturing and facility systems including IQ/OQ/PQ, maintenance and monitoring procedures and cleaning procedures
Work with a team of engineers and technicians to manufacture materials to support pre-clinical, clinical and commercial projects
Support R&D project teams through the use of process engineering tools such as root cause analysis, risk assessment and Six Sigma tools
Maintain accurate, detailed documentation throughout all phases of process development
BS/MS in a technical discipline (Engineering preferred)
10+ years of experience in process development or manufacturing operations in Medical Device, Pharmaceutical or other FDA regulated industry required
Thorough understanding Quality Risk Management (QRM) and Quality by Design (QbD) principles in accordance with ICH guidelines
Experience in process development activities in support of NDA filing
Demonstrated experience in DOE including experimental design, execution, data analysis and results summation
Demonstrated aptitude for ‘hands-on’ experimentation with an exemplary history as a “self-starter”
Ability to work as part of a cross functional team with manufacturing, research and development, analytical and biology staff
10 - 15% domestic travel as needed.
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