Engineer

ApTask Global Workforce (AGW) is seeking an Engineer with a technology company. This is a 23+ month contract opportunity with our client located in New Albany, OH. This is an onsite position.

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
• Work across a global, cross-functional team consisting of manufacturing, device and packaging design, capital projects, physical test methods, quality, and regulatory team members
• Lead effective 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 the manufacturing site
• Own documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports
• Support engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met
• Develop, track, and provide project dashboard updates
• Provide good communication plans to cross-functional teams and Process Engineer management

Requirements:

• Master's degree OR Bachelor's degree and 2 years of experience OR Associate's degree and 6 years of experience OR High school diploma/GED and 8 years of experience
• Experience as a Process Engineer with combination products
• Technology Transfer experience in a biotech, pharmaceutical, or GMP environment
• Strong English written and verbal communication skills
• Proficiency with MS Office
• Ability to apply project management and engineering science to production
• Strong teamwork and excellent interpersonal and communication skills

Desired skills:

• 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
• 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

Pay range: Up to $ 39.14 per Hour

Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, please apply!

ApTask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.