NPD Technical Project Manager — Pharma Manufacturing

Zenith Services Inc.; Palo Alto (CA); Sur place; USD 130 000 - 190 000; Plein temps

Résumé du poste

Zenith Services Inc. is seeking 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 will manage end-to-end projects, coordinate cross-functional teams, ensure regulatory compliance, and drive manufacturing readiness. A background in FDA-regulated environments and 3-5 years in PM is preferred.

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.

Responsabilités

• 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.

Connaissances

Project management

Cross-functional leadership

Regulatory compliance

Risk management

GMP knowledge

FDA regulations

Formation

Bachelor's in Mechanical Engineering

Outils

Siemens NX

SolidWorks

Creo

CATIA

Description du poste

Zenith Services Inc. is seeking 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 will manage end-to-end projects, coordinate cross-functional teams, ensure regulatory compliance, and drive manufacturing readiness. A background in FDA-regulated environments and 3-5 years in PM is preferred.