Jobs in the United States

25+ jobs

Group jobs by employerEmail me new jobs Save this search

Added 2 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 26 mins ago
People & Culture Business Partner
AeroVironment
Herndon, VA
Drive communication and change management efforts, including support for business transformations and M&A integration as applicable
Added 39 mins ago
VI
System Test Engineer
Viasat, Inc.
Carlsbad, CA · Germantown, MD · Reston, VA
- $149,500 to $224,500 USD / year
Shepherd test system deployment from hardware/software integration, to use in design verification and out to operations.
Added 1 hour ago
E
Sr Business Program Manager
Exelon
OAKBROOK TERRACE, IL
- $88,800 USD / year
…alignment with management models and principles and drive the integration of best practices. Perform various assignments including requests for financial and operational reports, data…
Added 1 hour ago
Manufacturing Engineering Internship - Automation & Industrial Engineering
Siemens
Buffalo Grove, IL
We are seeking a motivated Manufacturing Engineering Intern - Automation & Industrial Engineering to support continuous improvement, automation, and production optimization initiatives…
Added 1 hour ago
Senior Manager– AI Governance & Controls Engineering
AbbVie
North Chicago, IL
Own OneTrust (or successor risk-management platform) workflow integration for AI risk assessment orchestration, control tracking, documentation, and reporting.
Added 1 hour ago
Senior Air Permitting Specialist
Sargent & Lundy
Chicago, IL
This position is based on a hybrid work schedule and will require in-office work 3 days per week
Added 1 hour ago
Senior Data Engineer
Xenon7
Remote, United States
Process Engineering & Manufacturing Integration
Added 1 hour ago
Senior Data Engineer
Xenon7
Remote, United States
Process Engineering & Manufacturing Integration
Added 1 hour ago
Senior Data Engineer
Xenon7
Remote, United States
Process Engineering & Manufacturing Integration
Added 1 hour ago
Senior Data Engineer
Xenon7
Remote, United States
Process Engineering & Manufacturing Integration
Added 1 hour ago
Senior Data Engineer
Xenon7
Remote, United States
Process Engineering & Manufacturing Integration
Added 1 hour ago
Senior Data Engineer
Xenon7
Remote, United States
Process Engineering & Manufacturing Integration
Added 1 hour 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 1 hour ago
Principal / Sr. Principal Electrical Engineer
Northrop Grumman
Roy, UT
Provide technical support to Manufacturing, Procurement, Lab Integration, and Test organizations.
Added 1 hour ago
Sentinel Manager 2 - Supplier Management Team Lead (SMTL)
Northrop Grumman
Roy, UT
The SMTL will lead program execution across Business Management, Supply Chain, Engineering, Manufacturing, Integrated Product Teams, and Control Account Managers. The role will establish…
Added 1 hour ago
Senior QA Engineer, Operations Technology Transfer
Fujifilm
Holly Springs, NC
…lifecycle. This position interacts cross-functionally with Manufacturing, Supply Chain, Quality Control, Process Sciences, Validation, and various Client functions to ensure Quality…
Added 2 hours ago
Software Engineer Sys 5
Lam Research
Tualatin
‘Virtual Flex’ you’ll work 1-2 days per week on-site at a Lam or customer/supplier location, and remotely the rest of the time
Added 2 hours ago
Manufacturing & Capital Engineer 2
ARA Brand
Madison, AL
Seeking a Manufacturing & Capital Engineer 2 to support, build, optimize, and sustain the production capability and operational mindset within the Prototype, Manufacturing and Integration…
Added 2 hours ago
Staff Automation Engineer
Dexcom
Remote, United States
You lead the architecture, design, programming, commissioning, Software Verification and Validation (SWV&V), and lifecycle support of complex automated manufacturing equipment and control…
Added 2 hours ago
Electronics Engineer - 3
Northrop Grumman
Chandler
Lead cross-functional teams (including hardware, software, and manufacturing engineers) in both laboratory and field environments.
Added 2 hours ago
Engineer Electronics – Manufacturing Engineering (RF) 2/3
Northrop Grumman
Rolling Meadows
Experience with RF Electronic systems in manufacturing or design (software, firmware, etc.) environment.
Added 2 hours ago
Principal/Sr. Principal Engineer Microelectronic Semiconductors
Northrop Grumman
Apopka
Work closely with cross-functional teams in Process Engineering, Manufacturing, Quality, Integration, and R&D to ensure process stability, improve yield, high-volume ramp and drive…
Added 2 hours ago
Principal Engineer 2 / 3
Northrop Grumman
North Merritt Island
Design Booster hardware elements using processing knowledge and solid modeling software.
Added 2 hours ago
Energetics Manufacturing Engineer - Level 3 or 4
Northrop Grumman
Elkton
Must have a bachelors degree in STEM plus at least 5 years of related experience · Must have a bachelors degree in STEM plus at least 8 years of related experience

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

Report this job

Work requirements

Jobs in the United States