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Principal Process Development Engineer

4 months ago

Durham, United States EPM Scientific Full time

Principal Process Development Engineer Location : RTP, NC Working situation : On-site Level : Principal Engineer Our client, a global leader in eye care, is working to develop life-changing technology that improves patients' lives worldwide. With a commitment to excellence and innovation, we're at the forefront of advancing healthcare solutions. The

Principal Process Development Engineer

will play a key role in leading the design, optimization, and scale-up of manufacturing processes for cutting-edge drug products. As a key member of the team, you'll collaborate cross-functionally to ensure the seamless transition of processes from R&D formulation development phase to commercialization, while adhering to strict regulatory guidelines. The Principal Process Development Engineer will: Lead process development initiatives, from conceptualization to implementation, ensuring robust and efficient manufacturing processes for drug products. Conduct in-depth analyses and experiments to optimize process parameters, improve product quality, and enhance production efficiency. Drive technology transfer activities, ensuring phase-appropriate process development and scale-up for seamless transition to manufacturing. Collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to ensure alignment and smooth project execution. Oversee facility maintenance and operations, ensuring compliance with GMP standards and quality management systems. Lead systems qualification activities to ensure the reliability and performance of manufacturing equipment and processes. The Principal Process Development Engineer has the following qualifications: B.S. in Chemical Engineering, Pharmaceutical Sciences, or a related field 5+ years of industry experience Understanding of CFR Parts 210, and 211, ICH, and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications Company Benefits: Competitive salary and comprehensive benefits package Opportunities for professional growth and development A collaborative and inclusive work environment that fosters creativity and innovation Access to cutting-edge technologies and resources to support your success If you're ready to make a meaningful impact in the healthcare industry and contribute to the development of life-saving therapies, we'd love to hear from you. Apply now to join our client's dynamic team as a Principal Process Development Engineer and embark on a rewarding career journey

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