Engineer – Biotech Drug Delivery Device / Technical Transfer (JP15161)

3 Key Consulting•New Albany, OH

9d•Onsite

About The Position

In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing. 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 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.

Requirements

B.S. 3+ YOE, Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products.
Engineering Background.
Strong English written and verbal communication skills.
MS Office proficiency.
Smartsheet (project scheduling software) proficiency.
Project management experience in a supporting role.
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
Process Engineer experience.
Combination product experience.
Tech Transfer Experience.

Nice To Haves

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.
Familiarity with commercialization framework.
Program and Project Management skills (experience with MS Project, Smartsheet, and other project scheduling software is desired).
Proactive risk assessment, management, and mitigation.
Ability to lead and succeed in an ambiguous environment.
Strong project management skills.

Responsibilities

Organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.
Support and create project schedules.
Lead site assessment and manufacturing capabilities.
Update project dashboards.
Lead team meetings to progress the project towards final objectives.
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.
Lead effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.
Support New Product Introduction to manufacturing site.
Own documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.
Support engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.
Develop, track, and provide project dashboard updates.
Provide good communication plans to cross-functional teams and Process Engineer management.
Apply project management and engineering science to production.
Manage tech transfer projects from E2E for NPIs coming to AOH Site.