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Senior Validation Engineer Jobs in Raleigh, NC (NOW HIRING)

Fujifilm

CQV Engineer 2

Holly Springs, NC · On-site

Identifies potential risks and escalates to senior engineers or management for resolution * Creates, implements, and maintains equipment and system qualifications and validation protocols * Prepares ...

Fujifilm

CQV Engineer 2

Holly Springs, NC

Identifies potential risks and escalates to senior engineers or management for resolution * Creates, implements, and maintains equipment and system qualifications and validation protocols * Prepares ...

NC SECU

Model Risk Analyst

Raleigh, NC · Hybrid

... senior validation staff. * (30%) Validate the performance and controls of statistical models using provided model development documentation and communications with model developers. Document and ...

Alcami Corporation

Sr. Validations Specialist

Morrisville, NC · On-site

$77K - $106K/yr

Specific responsibilities include reviewing SOP's, composing/revising SOP's and validation master ... Bachelor's Degree in Engineering, Chemistry, Biology, or related field required. * 5+ years of ...

Next Step Systems

Senior Firmware Engineer

Durham, NC · On-site

$115K - $152K/yr

Senior Firmware Engineer, Durham, NC The Senior Firmware Engineer will work in the product ... validate and execute engineering verification test plans. - Document designs, implement tests ...

KBI Biopharma, Inc.

Senior Automation Engineer

Durham, NC · On-site

$100K - $131K/yr

A Senior Automation Engineer is responsible for providing technical support for ongoing operations ... Support Validation with the planning and execution of commissioning and validation protocols.

Tekniforce

Sr. DevOps Engineer

Raleigh, NC · On-site

$126K - $162K/yr

We are searching for a Sr. DevOps Engineer. This is a full-time permanent hire position with our ... Valid certificates in either AWS, Azure, Google or Oracle cloud is a huge plus

KBI Biopharma, Inc.

Senior Automation Engineer

Durham, NC · On-site

$100K - $131K/yr

A Senior Automation Engineer is responsible for providing technical support for ongoing operations ... Support Validation with the planning and execution of commissioning and validation protocols.

Raymond

Senior Structural Engineer

Raleigh, NC · On-site +1

$97K - $132K/yr

Pre-employment drug test, background check, and valid driver's license required. What We Offer: We provide a collaborative, technically driven environment where senior engineers can lead impactful ...

Apperture Solutions

Senior PAS-X MES Engineer

Raleigh, NC · Hybrid

$101K - $139K/yr

The Senior PAS-X MES Engineer will be a significant contributor and often the lead technical ... US Citizenship with a valid driver's license required * Demonstrated interest in software ...

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Senior Validation Engineer information

See Raleigh, NC salary details

$33

$62

$96

How much do senior validation engineer jobs pay per hour?

As of Jul 15, 2026, the average hourly pay for senior validation engineer in Raleigh, NC is $62.96, according to ZipRecruiter salary data. Most workers in this role earn between $50.24 and $71.49 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Senior Validation Engineer, and why are they important?

To thrive as a Senior Validation Engineer, you need a solid background in engineering, quality assurance, and regulatory compliance, typically supported by a relevant degree and experience in validation within regulated industries. Familiarity with validation protocols (IQ, OQ, PQ), statistical analysis tools, and systems like FDA 21 CFR Part 11 is crucial. Strong problem-solving, attention to detail, and effective communication skills help ensure successful project outcomes and cross-functional collaboration. These skills and qualifications are essential to maintain product quality, meet regulatory standards, and drive continuous improvement.

What does a Senior Validation Engineer do?

A Senior Validation Engineer is responsible for ensuring that products, systems, or processes meet regulatory standards and function as intended. They develop and execute validation protocols, analyze test data, and document results to confirm compliance with industry and company standards. Senior Validation Engineers often lead validation projects, collaborate with cross-functional teams, and mentor junior staff. Their work is critical in industries like pharmaceuticals, biotechnology, and manufacturing, where product safety and efficacy are essential.

What are some typical challenges faced by Senior Validation Engineers when leading validation projects?

Senior Validation Engineers often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and coordinating cross-functional teams. Balancing the needs of production, quality assurance, and regulatory affairs requires strong communication and project management skills. Additionally, troubleshooting unexpected validation failures and documenting results thoroughly are key aspects that demand both technical expertise and attention to detail.

What is the difference between Senior Validation Engineer vs Validation Specialist?

AspectSenior Validation EngineerValidation Specialist
CredentialsBachelor's or Master's in Engineering, Life Sciences, or related fields; often with certifications like GxP or CSVSimilar educational background; certifications like GxP or CSV are common
Work EnvironmentDesigns and oversees validation protocols in manufacturing, biotech, or pharmaceutical settingsExecutes validation tasks, tests, and documentation in similar environments
Employer & IndustryPharmaceutical, biotech, medical device companiesSame industries, often working under validation teams
Search & ComparisonOften compared for experience level and responsibilitiesCommonly searched together for validation roles

The main difference is that a Senior Validation Engineer typically leads validation projects, designs protocols, and oversees validation activities, while a Validation Specialist focuses on executing validation tests and documentation. Both roles require similar credentials and work in comparable environments, but the Senior Validation Engineer has more responsibility for planning and oversight.

What are the most commonly searched types of Validation Engineer jobs in Raleigh, NC? The most popular types of Validation Engineer jobs in Raleigh, NC are:
What are popular job titles related to Senior Validation Engineer jobs in Raleigh, NC? For Senior Validation Engineer jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Senior Validation Engineer jobs in Raleigh, NC look for? The top searched job categories for Senior Validation Engineer jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Senior Validation Engineer jobs? Cities near Raleigh, NC with the most Senior Validation Engineer job openings:
Senior Validation Engineer jobs near you
Infographic showing various Senior Validation Engineer job openings in Raleigh, NC as of July 2026, with employment types broken down into 88% Full Time, 7% Part Time, 1% Temporary, and 4% Contract. Highlights an 86% Physical, 5% Hybrid, and 9% Remote job distribution, with an average salary of $130,965 per year, or $63 per hour.
Engineer 3, Commissioning Qualification Validation

Engineer 3, Commissioning Qualification Validation

Fujifilm

Holly Springs, NC • On-site

Other

Posted 26 days ago

Fujifilm rating

8.4

Company rating: 8.4 out of 10

Based on 67 frontline employees who took The Breakroom Quiz

50th of 527 rated manufacturers

Job description

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
Overview
The CQV Engineer 3 supports the commissioning and qualification of equipment and systems for the site. This role performs validation activities to include but not limited to equipment set up, building dashboards, creating work orders, managing protocols, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards while ensuring a successful integration of CQV activities into site projects.
External US
What You'll Do
  • Configures, tests, and validates electronic systems to ensure the systems are properly qualified and validated per standards and regulatory requirements (e.g., Food & Drug Administration (FDA))
  • Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the field
  • Drafts and implements validation protocols
  • Executes validation activities (e.g., equipment set up, material readiness, and work orders)
  • Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized maintenance management system (CMMS)
  • Executes and manages validation protocols for manufacturing equipment, lab and admin, process support equipment, etc.
  • Develops dashboards in Tableau to visualize and analyze CQV data to track progress and trends
  • Identifies and assesses risks and escalates to senior engineers or management to develop and implement mitigation strategies
  • Develops, implements, and maintains equipment and system qualifications and validation protocols
  • Prepares and presents report packages for implementation into standard operating procedures (SOPs)
  • Prepares validation master plans for facilities, equipment, and systems
  • Provides guidance to junior engineers for drafting and implementing validation studies
  • Collaborates cross-functionally to ensure successful integration of CQV activities into projects
  • Other duties, as assigned

Minimum Requirements:
  • Bachelor's degree in Engineering with 5 years of experience in validation activities in facilities, commissioning, and systems
    qualification
  • Prior experience leading teams or projects
  • Temperature mapping, Thermal Data Loggers, and pre- and post-calibration procedure experience

Preferred Requirements:
  • Master's degree in Engineering with 3 years of experience in validation activities in facilities, commissioning, and systems qualification
  • Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry
  • Prior experience with mammalian cell culture process

Physical and Work Environment Requirements:
  • May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
  • Will work in environment operating a motor vehicle or Powered Industrial Truck.
  • Ability to discern audible cues. No X Yes
  • Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

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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About Fujifilm

Sourced by ZipRecruiter

With each Industry we enter, We’ve learned to Leverage and Adapt our knowledge, Expertise and rRsources to make the World a better place. When it comes to Innovating for a Healthier World and a more sustainable society, we’ll NEVER STOP. Fujifilm will contribute to the social challenges by creating new value in a wide range of business domains through innovation in Products, Services, and Technological Development. We launched our Healthcare Business with X-ray film in 1936. And now, We are developing our business in areas of prevention, diagnosis, and treatment as a Comprehensive Healthcare Company. We will never stop Innovating for a Healthier World.

Industry

Chemical manufacturing

Company size

10,000+ Employees

Headquarters location

Minato-ku, Tokyo, JP

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