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Quality Assurance Sr. Engineer

2 months ago

Holly Springs, United States FUJIFILM Holdings America Corporation Full time
Overview

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 solutionsto 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

About This Role

During Project phase:

Partners in the Quality oversight of Drug Product processes such as formulation, fill, inspection through to operational readiness, as well as provide oversight of validation program execution for these processes
Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility
Performs other duties, as assigned


During Operations:

Performs as subject matter expert within the QA team for the development of documents, processes, and procedures for the Drug Product program
Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports
Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems
Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
Ensures project and operational quality objectives are met within desired timelines
Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections
Performs other duties, as assigned

Minimum Requirements

Bachelor's degree in Life Sciences or Engineering with 9+ years of applicable industry experience OR
Master's degree in Life Sciences or Engineering and 6+ years of applicable experience OR
PhD in Life Sciences or Engineering and 3+ years of applicable experience
5+ years of experience in GMP Quality Assurance and/or similar role
Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility

Preferred Requirements

  • Prior experience of one or more of the following processes preferred.
  • formulation
  • aseptic filling
  • automated visual inspection
  • finished goods manufacturing.
  • Prior experience and knowledge with Quality Risk Management Principles
  • Advanced Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes
  • Expertise in cGMP & FDA regulations
  • Experience with startup projects or initiatives
  • Occasional opportunity for International and/or Domestic travel may be available

Working & Physical Conditions

Ability to stand for prolonged periods of time up to 30 minutes

Ability to sit for prolonged periods of time up to 120 minutes

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email 

FDBN_PNC@ .

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.