Intern: Commissioning Qualification and Validation (CQV)

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

We are looking for bright, enthusiastic students and recent graduates to join our summer internship program in Holly Springs.  This is a truly unique opportunity to see what goes into creating and shaping the future of our site.  Interns will work on-site in Holly Springs for up to 40 hours per week and will have the opportunity to interact with and learn from some of the most talented, experienced leaders in the industry.

Within CQV we are very busy generating documentation, traveling to vendor shops around the world to test equipment such as bioreactors and skids, and then preparing the processes and plans for going out onto the construction site as our equipment starts to arrive. 

An intern on this team would be integrated into ongoing work, supporting building out the needed processes for execution of testing, reviewing documentation, and partnering with our leads to identify and drive opportunities for improvement. 

Responsibilities:

• Work closely to support the department in development and implementation of processes
• Conduct research, ask questions, gather, and analyze data
• Prepare and/or review documents, reports and/or presentations
• Work closely with supervisor to determine internship project and achieve project goals
• Final presentation of assigned project at the conclusion of the internship
• Search for opportunities for continuous improvement
• Interact with department, cross-functional groups, and senior leadership
• Attend social and professional networking events
• Work with guidance and direction of CQV leadership to assess and develop the rationale for equipment family validation approach across different manufacturing tank systems
• Collect data from SMEs at our site and at the Denmark site (remotely) that will support development on the family approach rationale
• Improve the methods by which we plan and track execution of activities over time within CQV
• Work with the startup and turnover team on the development of commissioning documentation
• Participate in mechanical completion walk downs in the construction field
• Improve the methods by which we plan and track execution of activities over time within CQV
• Establish a method for technical review of documentation needed for factory acceptance testing
• Establish a means by which to track the number of reviews taking place, establishing a baseline for rework, a target for reducing rework, and suggestions on how to achieve the target
• Improve the methods by which we plan and track execution of activities over time within CQV

Requirements:

• Should be currently enrolled in an accredited university or college or have graduated within the past six months
• Ability to work on-site in Holly Springs up to 40 hours per week
• Excellent organizational, planning and time management skills
• Strong analytical and problem-solving skills
• Professional oral and written communication skills and an ability to present ideas clearly and concisely
• Ability to work well in a team environment
• Solution focused mindset and a willingness to ask questions and offer up ideas for improvement
• Detail oriented
• Comfortable with generating and reviewing technical documents if provided instruction and coaching
• Able to work independently and prioritize work with little direction
• Comfortable with performing against strict deadlines
• Comfortable with being outside for 1-2 hours at a time during walk downs
• Positive attitude and excitement to learn new things
• A focus on safety
• Comfortable working in MS Excel, Word, and PowerPoint
• Professionalism and commitment to be on site every day
• Willingness to learn how to work on various IT systems on site such as Kneat, Eida, and Blue Beam

Preferences:

• Chemical or Biomedical Engineering background
• Exposure to the construction industry or to biotech/biomanufacturing industry