Job Title: Engineer
Location: New Albany, OH
Duration: 24+ Months
Description:
Ideal Candidate: Experience: Biotech and pharma, GMP environment, manufacturing and tech transfer background, combination products.
Skills: Strong English written and verbal communication skills, MS Office, Smartsheet (project scheduling software), project management experience in a supporting role.
Desired: Engineering Background.
Key Responsibilities:
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 Client 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.
Basic Qualifications:
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
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 Client's commercialization framework.
Program and Project Management skills (experience with MS Project, Smartsheet's, 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.
...Responsibilities: Develop and manage advanced Tableau dashboards and reports, ensuring performance and responsiveness. Author and troubleshoot reports using Tableau Desktop and manage data sources. Create and optimize SQL queries for calculated fields within Tableau...
...Were looking for a **talented photo & video editor** who understands **real estate marketing** and knows how to make homes look their absolute best. If you love clean edits, smooth video transitions, and eye-catching reels this might be for you. #### **What Youll...
BOUTIQUE ASSISTANT ROLES AND RESPONSIBILITIES The Boutique Assistant elevates the in-store experience by consistently delivering memorable moments. They will execute best practices by optimizing hospitality and store amenities to create unique experiences. The Boutique...
...team of students through build and production process all the way through strike. Preferred Qualifications: Degree in technical theatre, minimum 2 years-experience in similar position. Expertise in developing hair and makeup concepts for musical theatre and ability...
...ll work closely with hiring managers to identify staffing needs and attract top talent. Source and recruit qualified CDL Class A drivers through multiple channels, including social media, job boards, referrals, and networking. Conduct phone and preliminary...