Principal Process Development Engineer

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 improve 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!