Sr. Engineer, QA Operations (Tech Transfer) - 2 Openings

Position Overview

The Sr. Engineer, Quality Assurance is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This position is responsible for ensuring the quality and compliance of initial Technology Transfer (TT) activities and supporting the continuous improvement and ongoing success of the TT lifecycle. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality objectives and initiatives are effectively delivered in a phase compliant manner.

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

 

• Participates in establishing programs and systems to ensure all GxP requirements associated with TT activities are phase appropriate and are in compliance• Ensures TT process and interdependencies are defined and well understood, and leverage data and technology to drive compliance, efficiency, and monitoring• Ensures integration of TT process with other Quality Systems (Deviation/CAPA, Change Control, Validation)• Provides guidance and quality oversight of cGMP activities supporting all TT deliverables through a phase-based delivery model including:

     a. Development and approval of TT Gap assessment(s)      b. Oversight of New Product Introduction (including Change Management mechanisms, as applicable)     c. Approval of Process Flow Diagram(s) and Process Controls Document(s), as applicable     d. Supports and approves of creation of new manufacturing documents in support of TT     e. Supports and approves of process validation protocols and documentation (PPQ, process-specific cleaning plans, etc.)     f. Supports and approves of new entries and records in support of TT (eBPR, BoM, etc.)

• Provides status reports and quality metrics to support management review process• Partners with cross-functional teams to ensure TT milestones are competed on time and within specification• Provides input, review, and approval for complex / critical deviations, CAPAs, change controls or other quality records in support of TT• Serves as TT SME for QA with regulators, clients, and company management• Assists QA senior management with departmental needs• Performs other duties, as assigned

 

Minimum Requirements:

 

• Bachelor’s in Life Sciences or Engineering or equivalent with 8+ years of applicable industry experience OR• Masters in Life Sciences or Engineering and 6+ years of applicable experience OR• PhD in Life Sciences or Engineering and 4+ years of applicable experience• Previous experience in Tech Transfer• Experience working in a GMP environment

 

Preferred Requirements:

 

• Working knowledge of Smartsheet, Trackwise, MasterControl, Veeva and/or Kneat validation software is a plus• Understanding of one or more of the following processes preferred:o cell culture/upstream processes   o large scale recovery/downstream processes   o aseptic processing• Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills.• High level of familiarity/understanding of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and/or validation methodologies • Understanding of Data Integrit