Quality Assurance Sr. Engineer (Drug Product)

Overview

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

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@fujifilm.com.

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