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Senior Security GRC Engineer, AI & Automation
American Express Global Business Travel
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AmexGBT’s Security GRC team is looking for a talented Senior Security GRC Engineer to design, build, and scale automation and AI-driven solutions that modernize our governance, risk, and…
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Associate Software Engineer
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Mechanical Engineer, Data Center Operations Engineering
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Java Full Stack Engineer with Spring boot/AWS Experience
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Providence, RI
- $86,000 to $99,000 USD / year
As a Java Full Stack Engineer with Spring boot/AWS exp, you will make an impact by designing and delivering scalable, cloud-native healthcare payer applications that improve payment…
Added 1 min ago
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Sr Staff Applications Operations Engineer – Engineering Tools Automation & AI Ops
GE Aerospace
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- $131,000 to $174,000 USD / year
Partner with cybersecurity and compliance teams to meet security, export control, and regulatory requirements (e.g., CMMC / NIST SP 800-171).
Added 1 min ago
Supplier Support Manufacturing Engineer
GE Aerospace
Providence, RI
Production Process Control: Define and oversee production processes, including tooling and equipment validation, ensuring alignment with design specifications and shop floor applications.
Added 1 min ago
AI Operations Administrator - Gravitee - Remote US
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…Information Security and AI GRC. Governance, policy, risk acceptance, control requirements, and independent control assurance remain with those teams, and design and build of enterprise…
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Sr. Principal Quality Engineer
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ForeScout Project Lead w/Public Trust
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Engineer, administer, and maintain ForeScout network security solutions supporting network access control (NAC) and cybersecurity automation initiatives.
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Mobile Engineer
CBRE
Suitland, MD · Upper Marlboro, MD · Forestville, MD · Camp Springs, MD
- $36 to $45 USD / hour
As a CBRE Mobile Engineer, you will be responsible for facility building maintenance focusing on retail sites within the Upper Marlboro area. You’ll be focused on several trades including…
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Principal Microelectronics Semiconductor Manufacturing Engineer/Sr. Principal Microelectronics Semiconductor Manufacturing Engineer
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…highest quality. The microelectronics semiconductor manufacturing engineer will support our highly automated SMT manufacturing environment. Manufacturing engineers are the process owners…
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Sr. Network Security Engineer
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The Senior Network Security Engineer is responsible for the configuration, deployment, and management of the customer’s NAC solution in a 24x7x365 environment. The senior engineer is…
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Associate Software Engineer
Highmark Health
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This job is an integral member of an agile software engineer team responsible for building scalable software applications across all digital channels to serve our customers. Responsible for…
Added 5 mins ago
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Java Full Stack Engineer with Spring boot/AWS Experience
Cognizant
Annapolis, MD
- $86,000 to $99,000 USD / year
As a Java Full Stack Engineer with Spring boot/AWS exp, you will make an impact by designing and delivering scalable, cloud-native healthcare payer applications that improve payment…
Added 5 mins ago
Mechanical Engineer, Data Center Operations Engineering
Meta
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Meta is seeking a Mechanical Engineer to join our Data Center Operations Engineering team. Our data centers are the foundation upon which our rapidly growing infrastructure efficiently…
Added 5 mins ago
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Java Full Stack Engineer with Spring boot/AWS Experience
Cognizant
Annapolis, MD
- $86,000 to $99,000 USD / year
As a Java Full Stack Engineer with Spring boot/AWS exp, you will make an impact by designing and delivering scalable, cloud-native healthcare payer applications that improve payment…
Added 5 mins ago
AI Operations Administrator - Gravitee - Remote US
SitusAMC
Annapolis, MD
…Information Security and AI GRC. Governance, policy, risk acceptance, control requirements, and independent control assurance remain with those teams, and design and build of enterprise…
Added 5 mins ago
Principal Engineer Manufacturing/ 4th Shift
Northrop Grumman
Baltimore, MD
Northrop Grumman Mission Systems Sector has an immediate need for 4th shift Manufacturing Process Engineer 3 to support the Final Assembly area within manufacturing . The primary location…
Added 19 mins ago
IT/OT Systems Engineer
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The IT/OT Systems Engineer is the primary IT contact for Operational Technology (OT) and Laboratory technology stakeholders at the Clayton and RTP sites. The role connects Manufacturing,…
Added 19 mins ago
Senior Manufacturing Systems Engineer - PLC Systems
Amgen
Holly Springs, NC
Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions for PLC based systems.
Added 19 mins ago
Engineer 2, MSAT
Fujifilm
Holly Springs, NC
Join a mission-driven team ensuring that every batch is safe, consistent, and inspection-ready. As an Engineer/Scientist 2 on our Process Validation team, you’ll help design, execute, and…
Added 19 mins ago
Staff Validation Engineer, Media Fills
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…work that makes a positive impact on a global scale. The Staff Engineer, Media Fill plays a critical role in supporting sterile/aseptic manufacturing operations by leading media fill…
Added 19 mins ago
Electrical Engineer - Power System Protection (Transmission) Job Details | Black & Veatch Family of Companies
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Black & Veatch is seeking an experienced Power System Protection Engineer with a preferred 5-10 years of experience to join our Protective Relay Settings Team . The ideal candidate has…
Added 19 mins ago
Lead Machining Process Engineer
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Process Engineering position associated with the manufacturing processes of Ceramic Matrix Composite (CMC) parts for aircraft engines in a production environment. Will focus on improvements…
Added 19 mins ago
Application Engineer II (PAS-X) - SDF
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…identified local manufacturing applications. Improve reliability of process control systems to meet current & projected customer, business & regulatory requirements through the following…

Fujifilm

Engineer 2, MSAT

Holly Springs, NC, United States

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Job details

Experience: Bachelor’s degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant industry experience; or
Posting language: English
Posted: Oct 8, 2026

Original job description

Position Overview

Join a mission-driven team ensuring that every batch is safe, consistent, and inspection-ready. As an Engineer/Scientist 2 on our Process Validation team, you’ll help design, execute, and document robust validation strategies - partnering across Tech Transfer, Manufacturing, Quality, and Engineering to keep processes reproducible under normal operating conditions.

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

About Us

We are a science-led biomanufacturing organization committed to patient safety, product quality, and operational excellence. We:

Champion data-driven, risk-based decision-making and continuous improvement
Foster an inclusive, respectful culture where diverse perspectives strengthen outcomes
Collaborate closely across functions to enable reliable commercial and clinical supply
Invest in learning, mentorship, and professional development

Responsibilities

Support the team with process validation requirements across equipment, systems, and manufacturing processes
Ensure regulatory compliance; assess change notifications related to process validation
Contribute to process validation strategy and execute all aspects of validation, including:
Process Performance Qualification (PPQ) runs
Continued Process Verification (CPV)
Other validation studies, as needed
Collaborate with Validation/CQV to support Performance Qualification (PQ) execution and at-scale assessments (e.g., worst-case soiling for cleaning validation, microbial hold, mixing validation)
Support process sub-teams throughout Technology Transfer (TT) phases
Facilitate generation of sampling plans for Process Validation Reports (PVRs) and investigations
Write and review documentation (e.g., validation campaign summaries, PPQ protocols and reports, impact assessments) for internal and external audiences
Contribute to developing and implementing training for manufacturing staff on process validation requirements
Support troubleshooting, process impact assessments, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA) in response to critical deviations, as needed
Support TT stage-gate reviews for manufacturing readiness (e.g., process characterization and validation, risk assessments and mitigation, robust supporting data for proposed changes)
Support creation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy, and extractables/leachables assessments; contribute to relevant site procedures and policies
Participate in continuous improvement initiatives with Manufacturing, Quality, Engineering, and Global teams (as applicable) to improve manufacturability, reliability, yield, and cost
Collaborate with Manufacturing to support commercial and clinical campaigns, including on-floor support
Perform other duties, as assigned

Minimum Qualifications

Bachelor’s degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant industry experience; or
Master’s degree in Engineering, Life Science, or Chemical Engineering with no previous experience

Preferred Qualifications

Experience using Quality Systems (e.g., deviation management system, change control, CAPA, document management system)
Experience using risk management and RCA tools
Experience working in a Good Manufacturing Practices (GMP) environment
Prior drug substance manufacturing experience, including process validation

Knowledge, Skills, and Abilities

Knowledge of regulatory audits and inspections and requirements (e.g., FDA 21 CFR Part 11)
Understanding of GMP, GLP, and GDP requirements
Knowledge of validation principles and techniques (IQ, OQ, PQ)
Strong problem-solving and project management skills
Excellent communication and teamwork skills; ability to present information clearly and adapt style to different audiences
Ability to provide constructive feedback to peers and leaders

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.

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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Posted Date 1 month ago (10/7/2026 3:17 PM)

Requisition ID 2026-39003

Job Locations US-NC-Holly Springs

Category Manufacturing

Company (Portal Searching) FUJIFILM Biotechnologies

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More about this job

Skills

Inspection
Chemical engineering
Quality control systems
Document management
Risk management
Good manufacturing practices
Good laboratory practices
SAP IQ
Problem solving
Project management
Communication skills
Teamwork
Give constructive feedback
ICIMS

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