Senior Principal Engineer

Position Summary

The Senior Principal Engineer will play a critical role in leading and executing engineering projects within the pharmaceutical manufacturing environment. 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.

Job Responsibilities

• Lead Engineering Projects: Drive end-to-end engineering projects from early-phase development through to commercialization, ensuring all deliverables meet company, regulatory, and customer requirements.
• Process Development & Optimization: Design, develop, and optimize manufacturing processes for parenteral drug products, focusing on efficiency, scalability, and compliance with regulatory standards (FDA, EMA, etc.).
• Technical Expertise: Provide in-depth technical expertise in the areas of drug product formulation, sterilization, filling, and packaging processes.
• Cross-Functional Collaboration: Collaborate closely with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless project execution and troubleshooting of any issues.
• Regulatory Compliance: Ensure all engineering activities are performed in compliance with applicable regulatory requirements, industry standards, and Exela Pharma Sciences' quality systems.
• Continuous Improvement: Identify and implement process improvements to enhance product quality, reduce production costs, and increase operational efficiency.
• Mentorship: Mentor and develop junior engineers, fostering a culture of continuous learning and professional development within the engineering team.
• Risk Management: Proactively identify potential risks in the manufacturing process and provide innovative solutions to mitigate them.
• Documentation & Reporting: Prepare and review technical documents, including specifications, reports, and process validation documents, to support regulatory filings and audits.

Experience Requirements

• Minimum of 10 years of experience in pharmaceutical engineering, with a strong focus on parenteral drug product development, manufacturing, and process optimization.
• Technical Skills:
  • 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.
  • Proficiency in process modeling, data analysis, and problem-solving techniques.
• Leadership: Proven ability to lead cross-functional teams, manage complex projects, and influence key stakeholders.
• Communication Skills: Strong verbal and written communication skills, with the ability to communicate technical concepts to both technical and non-technical audiences.
• Problem-Solving: Excellent analytical and troubleshooting skills, with the ability to think critically and develop innovative solutions to complex challenges.
• Project Management: Strong project management skills, with experience in managing timelines, budgets, and resources effectively.
• Experience in working with CMO/CDMO partners and managing client-facing interactions.
• Six Sigma or Lean Manufacturing certification.
• At least 6 years of experience in the pharmaceutical industry, preferably sterile injectables

Education Requirements

• Bachelor's or Master'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