DSJ Global is currently partnered with an award winning and fast-growing pharmaceutical manufacturing company who is looking to add a Senior Principal Engineer to their team in Lenior, NC. This position requires a highly skilled individual with extensive experience in process development, scale-up, and optimization of parenteral drug products. The ideal candidate will have strong leadership skills, technical expertise, and the ability to work cross-functionally to ensure the successful commercialization of complex drug products.
Responsibilities:
- Driving end-to-end engineering projects from early-phase development through to commercialization, ensuring all deliverables meet company, regulatory, and customer requirements.
- Design, develop, and optimize manufacturing processes for parenteral drug products, focusing on efficiency, scalability, and compliance with regulatory standards (FDA, EMA, etc.).
- Provide in-depth technical expertise in the areas of drug product formulation, sterilization, filling, and packaging processes.
- Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless project execution and troubleshooting of any issues.
- Ensure all engineering activities are performed in compliance with applicable regulatory requirements, industry standards, and quality systems.
- Identify and implement process improvements to enhance product quality, reduce production costs, and increase operational efficiency.
- Mentor and develop junior engineers, fostering a culture of continuous learning and professional development within the engineering team.
- Proactively identify potential risks in the manufacturing process and provide innovative solutions to mitigate them.
- Prepare and review technical documents, including specifications, reports, and process validation documents, to support regulatory filings and audits.
Requirements:
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or a related field. Advanced degree (MS or PhD) in a relevant engineering or scientific discipline is preferred.
- At least 6 years of experience in the pharmaceutical industry, preferably sterile injectables
- Extensive knowledge of drug product development and manufacturing processes, including aseptic processing, filling, and packaging.
- Strong understanding of GMP (Good Manufacturing Practice), FDA regulations, and international guidelines.
- Expertise in process validation, process control systems, and equipment qualification.
- Six Sigma or Lean Manufacturing methodology knowledge. Certification is a plus.