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!
