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Sr 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 · 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 · 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 ...

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 ...

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.

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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Sr Validation Engineer information

See Raleigh, NC salary details

$33

$62

$96

How much do sr validation engineer jobs pay per hour?

As of Aug 10, 2026, the average hourly pay for sr 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 some common challenges a Sr validation engineer faces when managing multiple validation projects simultaneously?

A Sr Validation Engineer often manages several validation projects at once, which can present challenges such as coordinating timelines, ensuring compliance with regulatory standards, and balancing cross-functional communication. Keeping detailed documentation and staying organized are essential, as unexpected equipment issues or shifting project priorities may arise. Successful engineers proactively communicate with quality, manufacturing, and R&D teams to mitigate risks, maintain project momentum, and deliver results within required deadlines.

What is a Sr validation engineer?

Sr Validation Engineers are experienced professionals responsible for ensuring that products, systems, or processes meet regulatory standards and function as intended. They lead validation projects, develop protocols, oversee testing, and document results to confirm compliance with industry regulations, such as those from the FDA or ISO. Their work is essential in industries like pharmaceuticals, biotechnology, and manufacturing, where product quality and safety are critical. Senior validation engineers also mentor junior staff and help improve validation processes within their organizations.

What are the key skills and qualifications needed to thrive as a Sr validation engineer?

To thrive as a Sr Validation Engineer, you need a solid background in engineering or life sciences, extensive experience with validation protocols, and a strong understanding of regulatory standards such as FDA, GMP, or ISO. Expertise in using validation software, risk assessment tools, and familiarity with documentation management systems is typically required, along with certifications like Six Sigma or ASQ CQE being advantageous. Exceptional problem-solving abilities, attention to detail, and effective communication skills help you lead teams and interact with cross-functional departments. These competencies are crucial for ensuring products and processes meet compliance standards, maintain quality, and support organizational success.

What is the difference between Sr Validation Engineer vs Validation Engineer?

AspectSr Validation EngineerValidation Engineer
Required CredentialsBachelor's/Master's in Engineering, certifications like CQE or ASQ, experience in validation processesBachelor's in Engineering or related field, some certifications preferred, less experience required
Work EnvironmentPharmaceutical, biotech, or manufacturing industries; leading validation projectsSupporting validation tasks under supervision, often in similar industries
Employer & Industry UsageUsed by companies requiring compliance with FDA, ISO, or GMP standardsCommonly used in manufacturing and quality assurance roles

The main difference between a Sr Validation Engineer and a Validation Engineer lies in experience, responsibility, and expertise. The Sr Validation Engineer typically leads validation projects, has more advanced certifications, and plays a strategic role in compliance. Validation Engineers support validation activities and often work under supervision. Both roles are essential in regulated industries like pharmaceuticals and manufacturing, but the senior role involves greater leadership and technical oversight.

What are popular job titles related to Sr Validation Engineer jobs in Raleigh, NC? For Sr Validation Engineer jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Sr Validation Engineer jobs in Raleigh, NC look for? The top searched job categories for Sr Validation Engineer jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Sr Validation Engineer jobs? Cities near Raleigh, NC with the most Sr Validation Engineer job openings:
Sr Validation Engineer jobs near you
Infographic showing various Sr Validation Engineer job openings in Raleigh, NC as of August 2026, with employment types broken down into 88% Full Time, 5% Part Time, and 7% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% Remote job distribution, with an average salary of $130,957 per year, or $63 per hour.

CQV Engineer 2

Fujifilm

Holly Springs, NC • On-site

Other

Re-posted 5 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 538 rated manufacturers

Job description

Position Overview
The CQV Engineer 2 supports the commissioning and qualification of equipment and systems for the site. This role coordinates with the CQV team to perform validation activities to include but not limited to equipment set up, building dashboards, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards.
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
  • 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
  • Coordinates the execution of 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 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 potential risks and escalates to senior engineers or management for resolution
  • Creates, implements, and maintains equipment and system qualifications and validation protocols
  • Prepares and presents report packages for implementation into standard operating procedure (SOPs)
  • Prepares validation master plans for facilities, equipment, and systems
  • Other duties, as assigned

Minimum Qualifications:
  • Bachelor's degree in Engineering with 2 years of experience in validation activities in facilities, commissioning, and systems qualifications

Preferred Qualifications:
  • Master's degree in Engineering with no prior experience
  • Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry
  • Prior experience with mammalian cell culture process

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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