Jobs in the United States

25+ jobs

Save this search

Added 3 mins ago
Quality Assurance Manager (Mgr Quality 3) - 30981
Huntington Ingalls Industries
Pocasset, MA
This opportunity resides with Uncrewed Systems (UxS), a business group within HII’s Mission Technologies division. Uncrewed Systems comprises unmanned underwater vehicles (UUVs), unmanned…
Added 3 mins ago
Principal Algorithm Engineer – Imaging / Ultrasound (ML)
Medtronic
Newton, MA
…growth and cross-functional collaboration as we work together to engineer the…
Added 3 mins ago
Lead, IPTL Software Engineer (Optical Space Systems) : Sign-on bonus ($30K max)
L3Harris
Wilmington, MA
Job Title: Lead, IPTL Software Engineer (Optical Space Systems) : Sign-on bonus ($30K max)
Added 3 mins ago
Sr Spec, Integration & Test Engineering
L3Harris
Wilmington, MA
The L3Harris AgileEO Metrology, Integration & Test department is seeking a Lead, Integration & Test Engineer to join our team and support one of our newer programs. AgileEO specializes in…
Added 3 mins ago
Software Engineer Co-op (January 2027)
RTX Corporation
marlborough, MA
The Software organization develops software applications, including integration and test on missiles, launchers, radars, naval systems, fire control and other complex systems. Our precision…
Added 3 mins ago
M
Engineering Intern Summer 2027 - Candidates Attending 2026 SHPE National Convention
Medtronic
Boston, MA · Newton, MA
- $26.5 to $45.25 USD / hour
…Engineering, Materials Science & Engineering, Computer Engineering, Software Engineering, Computer Science, or a related engineering discipline with an anticipated graduation date of Winter…
Added 3 mins ago
Sr. Machine Learning Engineer (Remote)
CrowdStrike
Boston, MA
…advanced AI-native platform. We work on large scale distributed systems, processing almost 3 trillion events per day and this traffic is growing daily. Our customers span all industries,…
Added 3 mins ago
PN
Data Scientist 3
Pacific Northwest National Laboratory
Boston, MA
- $140,200 USD / year
PNNL’s Environmental Subsurface Science Group is seeking a mid-level scientist or engineer with expertise developing PFLOTRAN to lead and contribute to projects modeling subsurface reactive…
Added 3 mins ago
AT
Senior II Site Reliability Engineer
Akamai Technologies, Inc.
Boston, MA
- $146,400 to $263,600 USD / year
…responsible for all of Akamai's bare-metal and VM hardware and software infrastructure platforms. CLP focuses on Compute's Linux kernels, operating systems, KVM/QEMU virtualization layer,…
Added 4 mins ago
AT
Senior II Site Reliability Engineer
Akamai Technologies, Inc.
Boston, MA
- $146,400 to $263,600 USD / year
In this role, you'll be at the forefront of Akamai Cloud platform software and hardware technologies. We're responsible for identifying performance bottlenecks and creating the supporting…
Added 4 mins ago
R&D Systems Engineer
J&J Family of Companies
Boston, MA
…generation and risk analysis for orthopedic robotic platforms. As a Systems Engineer you will work with cross-disciplinary teams, to develop system requirements, perform risk management,…
Added 4 mins ago
Senior Clinical Specialist, CRM- South Boston
Medtronic
Boston, MA
…possible reliability and quality in our products, processes, and systems by being accountable, having a voice and acting…
Added 44 mins ago
TRANSPORTATION ENGINEERING SPECIALIST - 11032026-82298
State of Tennessee
TN
…first half of TDOT's Graduate Transportation Engineering (GTE) Program. As part of a mandatory two-year program that includes rotations in core and elective disciplines, this position will…
Added 58 mins ago
Sr. Software Engineer, UI Developer Tooling (Hybrid, New York)
CrowdStrike, Inc.
NY · Boston, MA
…advanced AI-native platform. We work on large scale distributed systems, processing almost 3 trillion events per day and this traffic is growing daily. Our customers span all industries,…
Added 1 hour ago
Space Lasers Engineer, Satellites (Starlink)
SpaceX
Redmond, WA
As a SpaceX optical engineer, you will be responsible for free-space optical system design, validation, and operation. You will shape the future of laser communication systems and directly…
Added 1 hour ago
Optical Engineer, Satellites (Starlink)
SpaceX
Redmond, WA
As a SpaceX optical engineer, you will be responsible for free-space optical system design, validation, and operation. You will shape the future of laser communication systems and directly…
Added 1 hour ago
Ground Software Lead Engineer/Architect
Northrop Grumman
Gilbert, AZ
Northrop Grumman’s Space Sector is seeking a Ground Software Lead Engineer/Architect (Level 6) to join our team of highly qualified, diverse professionals within the Western Region Software…
Added 1 hour ago
Lead Principal Electrical Engineer III or IV (SBI LOE3)
Northrop Grumman
Chandler, AZ
At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems that impact people's lives around the world today, and for generations to come. Our…
Added 1 hour ago
Senior Data Engineer
Consumer Cellular
Scottsdale, AZ
Develop software that meets code quality standards and metrics.
Added 1 hour ago
RF Data Link Engineer II
RTX Corporation
tucson, AZ
The Advanced Effector Guidance Systems team is currently searching for Electrical Engineers who have experience designing wireless communication and data links. This role includes design…
Added 1 hour ago
Senior RF Data Link Engineer
RTX Corporation
tucson, AZ
The Advanced Effector Guidance Systems is currently searching for Electrical Engineers who have experience designing wireless communication and data links. This position focuses on…
Added 1 hour ago
Principal RF Data Link Engineer
RTX Corporation
tucson, AZ
The Advanced Effector Guidance Systems is currently searching for Electrical Engineers who have experience designing wireless communication and data links. This position focuses on…
Added 1 hour ago
Senior Software Safety / Senior System Safety Engineer
RTX Corporation
tucson, AZ
Collaborate with Program Management and government approval authorities from program startup through deployment to gain concurrence with software builds.
Added 1 hour ago
Software / System Safety Engineer II
RTX Corporation
tucson, AZ
This is an exciting opportunity for a highly motivated Software / System Safety Engineer II to join an innovative team in Tucson, AZ.
Added 1 hour ago
Program Quality Engineer II - Onsite Tucson, AZ
RTX Corporation
tucson, AZ
The Standard Missile 3 Block IIA (SM-3 IIA) Program Quality Engineer II in Tucson, AZ, will help implement strategic initiatives to improve quality and help manage customer and internal…

Fujifilm

QA Engineer, Drug Substance Manufacturing Operations

Holly Springs, NC, United States

Apply About employer

Applications open in a new tab.

Job details

Apply by: Nov 2, 2027
Posting language: English
Posted: Nov 2, 2026

Original job description

Position Overview

This position supports a 2/2/3 schedule from 6am-6pm.

The QA Engineer, DSM Operations 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. This role works 12-hour day shift on a 2-2-3 cadence, 0600-1800.

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.
Works 12-hour shift on 2-2-3 cadence, 0600-1800.
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).

Apply About employer

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

Report this job