QA Engineer - DSM
Company: FUJIFILM Holdings America Corporation
Location: Holly Springs
Posted on: March 17, 2023
Job Description:
Overview
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.We are looking for a Quality Assurance
Engineer, Drug Substance Manufacturing (DSM), who wants to
participate in our journey to establish the largest end-to-end cell
culture CDMO facility in North America. More importantly, someone
who wants to be a part of the largest growth journey that we in
FUJIFILM have ever entered. As the QA Engineer DSM, you will
directly impact the validation and start-up of a fully automated $2
billion Greenfield CDMO facility.During the project phase, the QA
Engineer for DSM will be responsible to help drive the Quality
oversight for the direction of all Drug Substance Manufacturing
processes through to operational readiness, as well as provide
oversight of validation program execution for these processes. You
will collaborate with other project teams, and with QA departments
at other sites to align strategies and procedures. -Once in
operations, you will continue to ensure that all DSM systems and
processes are operated/maintained in a validated state throughout
their lifecycle, with a focus on consistent policy administration,
QA oversight of day-to-day activities and resolution or mitigation
of issues occurring during operation. Additionally, you will
participate in optimization or improvement initiatives and support
regulatory agency and third-party inspections.
External US
Job Responsibilities
- Perform an SME role within the QA team for the development of
documents, processes, and procedures for the DSM program
- Assess the impact of system and process modifications and
maintain 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
- Provide 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
- Generate, review, and approve QA procedures for the validation
approach and lifecycle documents for Manufacturing Systems
- Generate, review, and approve QA documentation, procedures, and
processes for operational readiness objectives and QA support of
manufacturing operations in cGMP regulated facility
- Ensure that project and operational quality objectives are met
within desired timelines.
- Actively seek opportunities to collaborate and align with other
FUJIFILM Diosynth Biotechnologies sites to streamline processes and
maximize efficiency
- This role and the associated responsibilities will develop as
the project matures, and startup activities evolve into
operationsRequirementsWe are looking for a candidate with the
following background and skill sets:
- Collaborative attitude with the willingness to work with global
peers and cross-functional teams toward company and department
goals
- Education and experience appropriate to an SME level role in
Validation, cGMP manufacturing operations and/or Quality oversight,
in an FDA regulated facility, is required.
- High level of familiarity/understanding of validation of
production equipment, hygienic utilities, quality systems,
automation, manufacturing & IT Systems, and methodologies
- Understanding of GAMP5, Data Integrity, and application of 21
CFR Part 820 and Part 11 required
- Excellent oral and written communications skills and fluency in
English
- Working knowledge of ASTM E2500, Smartsheet and/or Kneat
validation software is a plus
- Understanding of one or more of the following processes
preferred:
- cell culture or fermentation
-
- large-scale recovery processes
- formulation and/or fill
- finished goods manufacturing
- Occasional opportunity for International and/or Domestic travel
may be available
- Training and/or familiarity with Quality Risk Management
principles preferredFDBN works with technical data, technology and
materials that are subject to U.S. export laws and regulations.
This position will require access to technical data, technology and
source code that is controlled under U.S. export laws and
regulations, including but not limited to the International Traffic
in Arms Regulations at 22 C.F.R. Parts 120 - 130 and Export
Administration Regulations in 15 C.F.R. Part 730 - 774, as may be
amended. To conform to these laws and regulations, applicants must
be U.S. citizens, lawful permanent residents of the U.S., protected
individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and
refugees) or otherwise eligible for an export authorization from
the U.S. Department of State or U.S. Department of Commerce. Offers
of employment will be contingent on the Company's ability to secure
an export authorization.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
lena.lee@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 -kind will be
paid.
Keywords: FUJIFILM Holdings America Corporation, Cary , QA Engineer - DSM, Engineering , Holly Springs, North Carolina
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