Engineer – Biotech, Drug Delivery Device & Packaging; JP

Engineer – Biotech, Drug Delivery Device & Packaging

Experience:

Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products.

Skills:

Strong English written and verbal communication skills, MS Office, Smart Sheet (project scheduling software), project management experience in a supporting role.

Desired:
Engineering Background

Job Description:

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 company 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.

Why is the Position Open? Supplement additional workload on team

Top Must Have

Skills:

• 1- 2 years of experience post-graduation
• Tech Transfer
• Engineering
• Project Management

Basic Qualifications:

Master's degree OR Bachelor's degree and 2 years of experience OR Associate's degree and 6 years of experience

Preferred Experience:

• 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 Company's commercialization framework.
• Program and Project Management skills (experience with MS Project, Smart Sheets, and other project scheduling software is desired).

Additional

Skills:

• Proactive risk assessment, management, and mitigation.
• Ability to lead and succeed in an ambiguous environment.
• Strong project management skills.

Red Flags:

• This is not a Project Manager role, it is an engineer role with project management skills.
• This position does not include relocation package.
• Prefer candidates in Ohio - Columbus/New Albany

Interview process:

• First interview with me (Hiring Manager) - 30 min
• Second interview with Omar Noorzai and Sofia Espinell (Interview Panel) - 45 min
• Third interview with Panel - 45 min