Associate Director Principal Engineer

Role: Associate Director Principal Engineer providing technical leadership in pharmaceutical process manufacturing, with a focus on oral solid dose (tablet and capsule) products. Objectives include optimizing manufacturing processes, supporting technology transfers, and ensuring compliance with cGMP standards. Responsibilities encompass troubleshooting process issues, executing process validation and scale-up activities, leading technology transfers, and implementing new manufacturing technologies, including Process Analytical Technologies. The role involves collaboration across Production, Engineering, Automation, and Quality teams, as well as mentoring Process Engineers and interns. High-value specifics include expertise in oral solid dose manufacturing, process validation (IQ/OQ/PQ), process development, continuous improvement (Lean, Six Sigma preferred), and statistical process control. The position requires leading cross-functional projects, supporting regulatory inspections, and maintaining compliance with industry standards. Location details are not specified. Candidates should possess a Bachelor’s degree in Science, Chemical Engineering, or related field, with at least 10 years’ experience in pharmaceutical process engineering, particularly in OSD manufacturing, and a strong understanding of cGMPs. Desired qualifications include a Master’s or PhD, Six Sigma certification, and experience with process capability analysis. The role emphasizes technical leadership, project management, and influence within a highly regulated environment.