Engineer

Summary

Our client is looking for a process engineer to organize Technology Transfer activities for Final Drug Product (FDP) manufacturing

Responsibilities

Responsibilities include supporting and creating project schedules, lead site assessment and manufacturing capabilities, update project dashboards, and leading team meetings to progress the project towards final objectives. You will work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members.

Your role will focus on leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.

Supporting New Product Introduction to a new manufacturing site.

Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.

Supporting engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.

Developing, tracking, and providing project dashboard updates.

Providing good communication plans to cross-functional teams and Process Engineer management.

Ability to apply project management and engineering science to production.

Strong teamwork and excellent interpersonal and communication skills

Required Skills

Experience in the Tech Transfer of Combination Product field, focusing on project management and/or manufacturing.

Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes.

Knowledge of Combination Product design controls and regulatory requirements on a global scale.

Program and Project Management skills (experience with MS Project, Smartsheet, and other project scheduling software is desired).

Preferred Skills

Proactive risk assessment, management, and mitigation.

Ability to lead and succeed in an ambiguous environment.

Strong project management skills.

Master’s degree OR

Bachelor’s degree and 2 years of experience OR

Associate’s degree and 6 years of experience OR

High school diploma/GED and 8 years of experience