Engineer – Biotech Drug Delivery Device / Technical Transfer (JP15161)
About The Position
3 Key Consulting is hiring Engineer – Drug Delivery Combination Product for a consulting engagement with our direct client, a leading global biopharmaceutical company. Ideal Candidate: B.S. 3+ YOE, Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products. Engineering Background. Skills: Strong English written and verbal communication skills, MS Office, Smartsheet (project scheduling software), project management experience in a supporting role. Position Overview: 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. 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 commercialization framework. Program and Project Management skills (experience with MS Project, Smartsheet, 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. Why is the Position Open? Supplement additional workload on team. Top Must Have Skills: - Process Engineer - must have combination product - Tech Transfer Experience Day to Day Responsibilities: Manage tech transfer projects from E2E for NPIs coming to AOH Site Basic Qualifications: 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 Red Flags: Not looking for a DS or DP Engineer No combination product experience Interview process: Video conference with: Manager (1:1) - 30 min Interview Panel 1: 45 min Interview Panel 2: 45 min
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
- Smartsheet (project scheduling software)
- 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 - must have combination product
- 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
- Supporting and creating project schedules
- Lead site assessment and manufacturing capabilities
- Update project dashboards
- Lead team meetings to progress the project towards final objectives
- 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
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What This Job Offers
Career Level
Mid Level
Number of Employees
1-10 employees
