Intern: CQV - Fujifilm

Overview

The Intern on the CQV team integrates 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.

Start Date: This internship is set to begin in May 2025 for an 11-week duration ending in August 2025.

Relocation: Please note this Internship Opportunity is designed to be 100% Onsite, 40 hours/week and a relocation/housing stipend is not provided.

Company Overview

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

Job Description

What You’ll Do

Under the direct supervision, support and guidance of the manager:

• Collaborates with manager and experienced Engineers on identified project(s). Creates and delivers presentation on identified project to Site Leadership Team at the conclusion of internship.• Works with guidance and direction of CQV leadership to assess and develop the rationale for equipment family validation approach across DSM systems and revise the validation project plans (VPP)• Assists with improvements to the methods by which CQV plans and tracks execution of activities over time• Assists with tracking progress of post-approval of CQV protocols• Participates in mechanical completion walk downs in the construction field, assist the STW teams in field walkdowns and shakedown readiness activities• Collaborate with CQV team to create methods 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• Assists the VTOP/CTOP readiness teams with progress tracking the document packages from the CM team• Identifies needs for Continuous improvement, by gathering feedback from users and implement improvement ideas for assigned projects• Performs other duties, as assigned

Basic Requirements

• Currently enrolled in an Associate's Degree program with a Life Sciences focus OR• Rising Junior or above and enrolled in an Engineering or Scientific Undergraduate or Master’s degree Program• Proficient in Microsoft Word, Excel, and PowerPoint• Wear the appropriate Personal Protective Equipment in an active construction site

Preferred Requirements

• Prior experience in Pharma/Biotech/Chemical Industry• Prior hands-on technical experience (in a laboratory or manufacturing environment)

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues
• Ability to ascend or descend ladders, scaffolding, ramps, etc
• Ability to stand for prolonged periods of time - up to 60 minutes
• Ability to sit for prolonged periods of time - up to 240 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).