Jobs in the United States

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Added 1 min ago
Aircraft Mechanic (Title 32) (Indefinite)
Army National Guard Units
Sandston, VA
…maintenance services exceeding AASF capabilities or time constraints. Controls and performs work assignments based upon priorities, workload, availability of parts, facilities, material and…
Added 1 min ago
2027 Associate Systems Engineer (AHT) - Dulles VA
Northrop Grumman
Dulles, VA
…these modes and mitigation through autonomous or operational controls. Responsibilities will also include interaction with program, functional and customer…
Added 1 min ago
Principal Identity Cybersecurity Engineer
The MITRE Corporation
McLean, VA
Must have an active Top Secret U.S Government issued Security Clearance
Added 1 min ago
Observability Pipeline Engineer
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…the tele met ry underneath it. As an observability pipeline engineer on our team, you'll own the tele met ry that feeds logging, monitoring, and security analytics across commer cia l and…
Added 10 mins ago
SO
Platform Specialist - OIT Transparency Posting (Remote From Anywhere In CO)
State of Colorado
CO
- $100,000 to $110,000 USD / year
As a Platform Specialist with the Office of Information Technology (OIT), you will engineer, configure, automate, and deploy the state’s shared content management and electronic signature…
Added 16 mins ago
CAD Designer/Drafter
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Milwaukie, OR
The Product CAD Designer plays a crucial role in contributing to the product design process, either independently or under the guidance of a project engineer. This position involves…
Added 16 mins ago
Sr Quality Engineer
MKS Instruments Inc
Klamath Falls, OR
As the Senior Quality Engineer at the MKS ESI Klamath Falls manufacturing site, you will serve as the site’s primary quality resource and provide hands-on support for the production of…
Added 28 mins ago
Investment Management Engineer
Samsung Austin Semiconductor, LLC.
1530 FM 973 Taylor, TX
The Investment Management Engineer will support the management and financial oversight of all Korea-funded investments for Samsung Austin Semiconductor new Fabs, including construction,…
Added 28 mins ago
Infra Cost Engineer
Samsung Austin Semiconductor, LLC.
1530 FM 973 Taylor, TX
The Cost Engineer will be responsible for managing, analyzing, and optimizing Infrastructure operational expenses (OPEX) and tool hook-up costs at Samsung Austin Semiconductor. This…
Added 32 mins ago
W
Data Engineer, Security Analytics
Wayve
Sunnyvale, CA
- $186,100 to $243,300 USD / year
As a Data Engineer, you’ll join the Security team and build the data and automation capabilities that underpin our security program. You’ll work across Security to design scalable data…
Added 33 mins ago
Release Train Engineer
Regions
Charlotte, NC · Hoover, AL · Atlanta, GA
At Regions, the Release Train Engineer manages and optimizes the flow of value through the Agile Release Train. An Engineer at this level leads Agile Release Trains (ART), resolves and…
Added 33 mins ago
KL
Engineer II HVAC Technician
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- $30 to $33 USD / hour
Must have full range of reach motion to reach overhead and below the knees · Must possess basic computational ability
Added 37 mins ago
Senior Manager– AI Governance & Controls Engineering
AbbVie
North Chicago, IL
Additionally, the Senior Manager leads and develops a high-performing AI Controls Engineering team - including direct oversight of the Principal Quality Engineer, AI Controls Engineering…
Added 38 mins ago
Senior Front-End and Agentic-UI Engineer
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The Senior Software Engineer leads the design, development, and deployment of complex features in the web user experience for the Evolent Platform. This role builds high-performance React…
Added 51 mins ago
DCIM Engineer II
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The Data Center Infrastructure Management (DCIM) Engineer II is responsible for the management and administration of the Electric Power Monitoring Systems (EPMS) and Building Management…
Added 51 mins ago
DCIM Engineer III
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United States
The Data Center Infrastructure Management (DCIM) Engineer III is responsible for the management and administration of the Electric Power Monitoring Systems (EPMS) and Building Management…
Added 53 mins ago
Senior QA Engineer, Sterility Assurance
Fujifilm
Holly Springs, NC
The Senior QA Engineer, Sterility Assurance is responsible for providing Quality Assurance oversight of the site’s sterility assurance program to ensure the manufacture of sterile…
Added 1 hour ago
Staff Systems Engineer
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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 1 hour ago
Quality Engineering
OXFORD GLOBAL RESOURCES, LLC
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Added 1 hour ago
Quality Engineer
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Added 1 hour ago
Engineer-Protection & Controls
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Engineer-Protection & Controls location: SALT LAKE CITY,UT,US,84116 Company: PacifiCorp ## POWER YOUR GREATNESS PacifiCorp is seeking customer-centric candidates to grow and sustain our…
Added 1 hour 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 1 hour ago
AH
Engineer II HVAC Technician
Azul Hospitality
Koloa, HI
- $30 to $33 USD / hour
Must have full range of reach motion to reach overhead and below the knees · Must possess basic computational ability
Added 1 hour ago
Rapid Remediation Crew Lead
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Added 1 hour ago
Manager Information Security
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Engineer AI solutions for risk management, such as evidence collection, control testing, risk register enrichment, and automated assessment support.

Fujifilm

Senior QA Engineer, Operations Technology Transfer

Holly Springs, NC, United States

Apply on uscareershub-fujifilm.icims.com About employer

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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