Engineer – Biotech, Drug Delivery Device & Packaging (JP14627) jobs in United States
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3 Key Consulting, Inc. · 2 months ago

Engineer – Biotech, Drug Delivery Device & Packaging (JP14627)

3 Key Consulting is hiring an Engineer for a consulting engagement with a leading global biopharmaceutical company. The role involves organizing Technology Transfer activities for Final Drug Product manufacturing, supporting project schedules, and collaborating with cross-functional teams to enhance controls in a GMP setting.

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Responsibilities

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

Qualification

Tech TransferProject ManagementGMP EnvironmentCombination ProductsMS OfficeSmartSheetCommunication SkillsTeamwork

Required

1- 2 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

Preferred

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, SmartSheets, and other project scheduling software is desired)

Company

3 Key Consulting, Inc.

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3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.

H1B Sponsorship

3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)

Funding

Current Stage
Growth Stage

Leadership Team

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Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
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Company data provided by crunchbase