Jobs in the United States

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Added 1 min ago
Systems Engineer
XMSTART
Aurora, CO
Supporting requirements development, traceability, and change management
Added 1 min ago
Systems Engineer
XMSTART
Chantilly, VA
Supporting requirements development, traceability, and change management
Added 3 mins ago
Senior Application Engineer
Henkel group
Madison Heights · Madison Heights, MI, MI
Selected candidate will be in the office 5 days per week unless traveling on business or taking paid time off
Added 3 mins ago
Sr. Quality Engineer
Henkel group
Calhoun · Calhoun, GA, GA
Identify and implement opportunities for process optimization within the quality department.
Added 4 mins ago
Senior Full Stack Software Engineer
ServiceTitan, Inc.
Remote, United States
We're looking for a Senior Full Stack Engineer to join a small team building our two-sided Consumer Marketplace from the ground up. This is a 0 to 1 opportunity, a startup within an…
Added 10 mins ago
Staff Systems Engineer
Halo Industries, Inc.
Santa Clara, CA
As a Staff Systems Engineer at Halo Industries, you will play a crucial role in the development, integration, and lifecycle management of our next-generation semiconductor manufacturing…
Added 12 mins ago
Quality Engineer
GSC FOUNDRIES
SPANISH FORK, UT
Added 13 mins ago
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System Integration Engineer – Tech Lead
Intermountain Health
West Valley City, UT
- $153,192 to $163,192 USD / year
Job Title: System Integration Engineer – Tech Lead
Added 13 mins ago
Sentinel Project Change Engineering Section Manager 2
Northrop Grumman
Roy, UT
…responsibilities will be personnel performance management, process familiarization and training for Section members, as well as staffing of roles on projects. You will also fulfill a…
Added 13 mins ago
Software Engineer - AI
SHI
Salt Lake City, UT
Build applications that process and present data from enterprise systems, databases, and external services.
Added 13 mins ago
Product Manager
Meta
Salt Lake City, UT
Integrate data, usability studies, research, and market analysis into product strategies and requirements to enhance user satisfaction and improve engineer productivity
Added 13 mins ago
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Mechanical Engineer - Non Oily Waste (Part-time)
Noblis
Salt Lake City, UT
- Part-time
…Warfare Center (NSWCPD) and their missions’ to enable research, development, test and evaluation, acquisition, engineering, systems integration, in-service and fleet engineering with…
Added 13 mins ago
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Federal Oracle Health Automation Engineer - Eggplant
Oracle
Salt Lake City, UT
- $23.8 to $56.83 USD / hour
The Federal Test Automation team is seeking a Staff Automation Engineer to support the Federal VA project. This role is responsible for designing, developing, and executing automated…
Added 13 mins ago
Senior Director Software Engineering
Capital One
Salt Lake City, UT
As a Senior Director, Full-stack Engineer at Capital One, you will lead high-performing engineering teams working to define the future of banking in the cloud. You will partner closely with…
Added 13 mins ago
Core Senior .NET Software Engineer
Evolent
Salt Lake City, UT
The Senior Software Engineer leads the design, development, and deployment of complex software solutions, ensuring scalability and maintainability. This role architects and implements…
Added 13 mins ago
Sr Staff Software Engineer, Stream Integrations
MONTROSE ENVIRONMENTAL GROUP
SALT LAKE CITY, UT
…control over their real-time data. We are looking for a Sr Staff Engineer to help build our core data platform which ingests, enriches, transforms, shapes, and routes data from and to…
Added 13 mins ago
Project Engineer - Instrumentation and Electrical
Marathon Petroleum Corporation
Salt Lake City, UT
RESPONSIBILITIES:• Applies project management skills across all phases: development, justification, design, construction, and start-up• Manages multiple projects/programs safely,…
Added 13 mins ago
Quality Engineer II
Medtronic
Salt Lake City, UT
This position is based in West Valley, Utah and requires an onsite work schedule five (5) days per week at the manufacturing facility
Added 13 mins ago
CCaaS Information Systems Engineer III
University of Utah
Salt Lake City, UT
Working Title CCaaS Information Systems Engineer III
Added 13 mins ago
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Automated Test Engineer
Eliassen Group
Salt Lake City, UT
- $40 to $50 USD / hour
Our client seeks an Automated Test Engineer to support Hivemind by monitoring and maintaining large volumes of automated tests, troubleshooting failures, and driving bug resolution across…
Added 15 mins ago
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Staff, Software Engineer | Bentonville, Arkansas
Walmart
BENTONVILLE, AR
- $110,000 to $220,000 USD / year
As a Staff Software Engineer, you will lead the design and delivery of scalable platform capabilities, driving the full software development lifecycle from coding to deployment and…
Added 15 mins ago
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(USA) Staff, Software Engineer
Walmart
Sunnyvale, CA
- $143,000 to $286,000 USD / year
The (USA) Staff, Software Engineer plays a critical role in delivering scalable platform capabilities and driving the full software development lifecycle, including design, coding, testing,…
Added 15 mins ago
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(USA) Senior, Software Engineer
Walmart
SUNNYVALE, CA
- $117,000 to $234,000 USD / year
As a Senior Software Engineer, you will lead the design, development, and delivery of scalable software solutions that align with business objectives. This role requires expertise in…
Added 18 mins ago
Senior QA Engineer, Operations Technology Transfer
Fujifilm
Holly Springs, NC
The Senior Engineer, QA Operations Technology Transfer is responsible for establishing and maintaining a robust and efficient Technology Transfer program at the Holly Springs, NC site. This…
Added 24 mins ago
Product Manager
Meta
Washington, DC
Integrate data, usability studies, research, and market analysis into product strategies and requirements to enhance user satisfaction and improve engineer productivity

Fujifilm

Senior QA Engineer, Operations Technology Transfer

Holly Springs, NC, United States

Apply on uscareershub-fujifilm.icims.com About employer

Applications open in a new tab.

Job details

Apply by: Nov 12, 2027
Posting language: English
Posted: Nov 12, 2026

Original job description

Position Overview

The Senior Engineer, QA Operations Technology Transfer 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

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive - what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

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

Knowledge, Skills, and Abilities

Ability to work in a highly regulated environment and follow regulatory requirements and Good Manufacturing Practices (GMP).
Ability to manage multiple assignments while meeting timelines in a GMP environment.
High level of familiarity/understanding of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and/or validation methodologies.
Advanced ability to work in a collaborative team environment and act as SME for tasks associated to their role.
Advanced ability to work independently in a high-paced team environment, meet deadlines, and prioritize work.
Ability to perform tasks such as SOP creation, program development, training curricula to deliver on operational and inspection readiness goals.
Excellent organizational and critical thinking skills.
Excellent communication skills (written and oral) to collaborate effectively with peers, department management and cross-functional peers.
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.
Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

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.
4+ years of experience working in a GMP environment.

Preferred Qualifications

Working knowledge and experience with Smartsheet, Trackwise, MasterControl, Veeva and/or Kneat validation software.
Understanding of one or more of the following processes:
Cell culture/upstream processes
Large scale recovery/downstream processes
Aseptic processing.
Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills.
Training and/or familiarity with Quality Risk Management principles.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

Ability to ascend or descend ladders, scaffolding, ramps, etc…
Ability to stand for prolonged periods of time for up to 30 minutes.
Ability to sit for prolonged periods of time for 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 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.

*LI-Onsite

EEO Information

Fujifilm is committed to 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.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).

Apply on uscareershub-fujifilm.icims.com About employer

More about this job

Skills

Regulatory compliance
Process improvement
Supply chain management
Quality control
Quality control systems
Change management
Documentation
Cleaning
Good manufacturing practices
Work independently
Meet deadlines
Inspection
Critical thinking
Communication skills
Smartsheet
MasterControl
Risk management

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Work requirements

Jobs in the United States