Sr Engineer QA Operations Tech Transfer - 2 Openings

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 crossfunctionally 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.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll 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 phasebased 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 processspecific 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 crossfunctional 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:

Bachelors 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 Integrity and application of 21 CFR Part 820 and Part 11
Occasional opportunity for International and/or Domestic travel may be available

Training and/or familiarity with Quality Risk Management principles preferred.

Physical and Work Environment Requirements:

Ability to ascend or descend ladders scaffolding ramps etc.

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

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

Ability to conduct work that includes moving objects up to 10 pounds.

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 viaemail 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.

Fujifilm is committedto 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .