Senior Engineer – Biotech, Drug Delivery Device & Packaging; JP

Senior Engineer – Biotech, Drug Delivery Device & Packaging

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

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

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

• 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.

Supplement additional workload on team

• 4- 5 years of experience post-graduation
• Tech Transfer
• Engineering
• Project Management

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

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

• 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

- First interview with me (Hiring Manager) - 30 min

- Second interview with Omar Noorzai and Sofia Espinell (Interview Panel) - 45 min

- Third interview with Daniel Davila and Ahmad Kamel (Interview Panel) - 45 min