Job Description

DSJ Global is currently partnered with an award winning and fast-growing pharmaceutical manufacturing company who is looking to add a Principal Engineer to their team in Raleigh, 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.

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