Technical Project Manager - New Product Development (NPD)

Technical Project Manager - New Product Development (NPD) Domain: Pharmaceutical / Manufacturing Job Description: We are looking for an experienced Technical Project Manager with a strong Mechanical Engineering background to lead New Product Development (NPD) projects in a pharmaceutical manufacturing environment. The ideal candidate should have experience managing engineering projects, manufacturing processes, regulatory compliance, and product development within FDA-regulated environments. Key Responsibilities: Lead end-to-end NPD/NPI projects from concept through design, development, testing, validation, and production launch. Manage project timelines, budgets, resources, risks, and deliverables. Coordinate mechanical design, manufacturing, quality, regulatory, validation, and supply chain teams. Oversee mechanical product development, prototyping, and design reviews. Drive Design for Manufacturing (DFM), Design for Assembly (DFA), and manufacturing readiness. Ensure compliance with FDA regulations, GMP, and applicable industry standards. Coordinate regulatory documentation, design controls, risk assessments, and change control processes. Support audits, CAPA, deviations, validation activities, and regulatory submissions, as applicable. Manage engineering changes, technical documentation, and stakeholder communication. Required Skills & Qualifications: Bachelor's degree in Mechanical Engineering or related field. 8-15 years of engineering experience, including 3-5 years in technical project management. Strong experience in Mechanical Engineering and NPD/NPI. Knowledge of CAD tools such as Siemens NX, SolidWorks, Creo, or CATIA. Experience with DFM, GD&T, FMEA, and design validation. Knowledge of FDA regulations, GMP, regulatory compliance, and quality management systems. Experience with regulatory documentation, change control, CAPA, and validation. Pharmaceutical, medical device, or FDA-regulated manufacturing experience preferred. Strong project management and cross-functional leadership skills. #J-18808-Ljbffr Zenith Services Inc.