Jobs in the United States

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Added 1 min ago
Controls Subject Matter Expert
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Demonstrated ongoing AI skill development (e.g., prompt/context engineering, agent orchestration) and staying current with emerging AI technologies
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Territory Executive - Illinois
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…rapidly and hiring top talent with leading AI skills across engineering, sales, product, marketing, and beyond as we build the leading digital operations…
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Senior Technical Program Manager
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Boise, ID
- $119,600 to $215,400 USD / year
Materially leading the Product Development Process and the full software development lifecycle and release process for AI products and solutions
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Cyber Security Manager - Diego Garcia
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Amentum, a global leader in advanced engineering, technical, and professional services serving the US government, allies and critical infrastructure sectors, is seeking an FRCS…
Added 17 mins ago
IT Program Manager
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Lead, mentor, and develop program staff through performance management, career development, retention, and succession planning.
Added 33 mins ago
NS
GENERAL ENGINEER
Naval Sea Systems Command
Naval Base Newport, RI
- $142,452 to $197,200 USD / year
…Team Submarine Technical Authority enterprise in the design, development, operation, and maintenance of USW Electromagnetic critical systems by coordinating and engaging directly with Team…
Added 44 mins ago
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IT SPEC (SYSADMIN)
Air National Guard Units
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- $75,278 to $97,867 USD / year
…coordination with others outside the organizational unit and development of project controls. Experience that required adaptations of guidelines or precedents to meet the needs of the…
Added 44 mins ago
VH
Biomedical Equipment Support Specialist
Veterans Health Administration
Altoona, PA
- $45,127 to $107,554 USD / year
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Added 44 mins ago
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Minneapolis, MN
- $127,286 to $165,474 USD / year
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Added 46 mins ago
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IT Specialist (Network) (Title 32) (Permanent)
Air National Guard Units
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Field Implementation Engineer
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- $95,500 to $149,200 USD / year
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Supervisory IT Specialist
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Location Negotiable After Selection
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Executes Assault Zone Support Program Planning, Operations, and Related Training Requirements.
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Chesapeake, VA · Hampton County, VA
- $61,008 to $140,686 USD / year
…facility. Works in support of the medical equipment management program. In addition to duties at the full performance level, the BME assists in the maintenance of medical servers and…
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IT SPEC (INFOSEC)
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INSTRUCTIONAL SYSTEMS SPECIALIST
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Buckley AFB, CO
- $99,800 to $129,742 USD / year
…Comprehensive knowledge of a wide variety of instructional development methods sufficient to develop and make substantial adaptations or extensions of instructional materials for specialty…
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Bachelor’s Degree in Electrical Engineering from an ABET-accredited program.
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Bachelor’s Degree in Electrical Engineering from an ABET-accredited program.
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Sr. Electrical Engineer (PE)
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Bachelor’s Degree in Electrical Engineering from an ABET-accredited program.
Added 1 hour ago
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Sr. Electrical Engineer (PE)
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Bachelor’s Degree in Electrical Engineering from an ABET-accredited program.
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Sr. Electrical Engineer (PE)
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Bachelor’s Degree in Electrical Engineering from an ABET-accredited program.

Fujifilm

QA Engineer, Drug Substance Manufacturing

Holly Springs, NC, United States

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Job details

Apply by: Nov 5, 2027
Posting language: English
Posted: Nov 5, 2026

Original job description

Position Overview

The Engineer, QA Drug Substance Manufacturing is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues.

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

Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program.
Assesses the impact of system and process modifications and maintains 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.
Provides 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.
Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems.
Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
Ensures project and operational quality objectives are met within desired timelines.
Collaborates and aligns with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
Performs other duties as assigned.

Knowledge, Skills, and Abilities

Strong verbal and written communication skills to partner with different teams and stakeholders.
Excellent oral and written communications skills and fluency in English.
Strong time management, ability to meet tight deadlines to ensure effective prioritization of tasks.
Ability to think critically and have superior problem-solving skills.
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.
Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes.
Team based attitude and ability to build relationships and communicate effectively with others.
Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
Basic knowledge and application of cGMP compliance and other related regulations.
Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.
Occasional opportunity for International and/or Domestic travel may be available.
Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience; OR,
MS in Life Sciences or Engineering and 3+ years of applicable experience; OR,
PhD in Life Sciences or Engineering and with 1+ years of applicable experience.
3+ years of experience working in a GMP regulated environment.
Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Preferred Qualifications

Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software.
Experience with startup projects or initiatives.
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 discern audible cues.
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 activities using repetitive motions that include wrists, hands, and/or fingers.
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).

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More about this job

Skills

Quality assurance
Change management
Documentation
Inspection
Communication skills
Time management
Prioritization
Problem solving
Quality control systems
Regulatory compliance
Good manufacturing practices
Smartsheet
MasterControl
Risk management

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