Infotree Global Solutions
Senior Engineer (Tech Transfer/Combination Products)
Infotree Global Solutions, New Albany, Ohio, United States, 43054
Overview
Senior Engineer (Tech Transfer/Combination Products) 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, and lead team meetings to progress the project towards final objectives. Collaborate with a global, cross-functional team including manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory teams. Lead 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, support engineering with Process Transfer Documents (PTD), protocols, and reports. Support engineers with Make-a-Batch activities to ensure sending/receiving site expectations are met. Develop, track, and provide project dashboard updates. Provide effective communication plans to cross-functional teams and Process Engineer management. Apply project management and engineering science to production; work with strong teamwork and communication. Qualifications
Basic Qualifications: Bachelor’s degree and 2 years of experience; OR Associate’s degree and 6 years; OR High school diploma/GED and 8 years. Preferred Experience: Experience in Tech Transfer of the 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. Required Competencies
Strong English written and verbal communication skills. MS Office proficiency and Smartsheet (project scheduling software). Project management experience in a supporting role; strong teamwork and interpersonal skills. Other
Schedule is typically 8am - 5pm with some flexibility; overtime 10% of time during peak season may be expected. Location: New Albany, OH (as per posting).
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Senior Engineer (Tech Transfer/Combination Products) 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, and lead team meetings to progress the project towards final objectives. Collaborate with a global, cross-functional team including manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory teams. Lead 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, support engineering with Process Transfer Documents (PTD), protocols, and reports. Support engineers with Make-a-Batch activities to ensure sending/receiving site expectations are met. Develop, track, and provide project dashboard updates. Provide effective communication plans to cross-functional teams and Process Engineer management. Apply project management and engineering science to production; work with strong teamwork and communication. Qualifications
Basic Qualifications: Bachelor’s degree and 2 years of experience; OR Associate’s degree and 6 years; OR High school diploma/GED and 8 years. Preferred Experience: Experience in Tech Transfer of the 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. Required Competencies
Strong English written and verbal communication skills. MS Office proficiency and Smartsheet (project scheduling software). Project management experience in a supporting role; strong teamwork and interpersonal skills. Other
Schedule is typically 8am - 5pm with some flexibility; overtime 10% of time during peak season may be expected. Location: New Albany, OH (as per posting).
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