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Validation Engineer Jobs in Raleigh, NC (NOW HIRING)

Intellectt INC

"cleaning validation"

Holly Springs, NC · On-site

Role:CQV Engineer - Cleaning Validation Location: Holly Springs, NC Key Responsibilities: * Execute and document cleaning validation protocols per FDA/ICH guidelines (ALCOA principles). * Apply ...

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Danaher

Senior Engineer, Process Validation

Raleigh, NC · On-site +1

$100K - $130K/yr

The Senior Engineer, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines. This ...

Intellectt INC

CQV Engineer

Holly Springs, NC · On-site

Coordinate with engineering, automation, validation, quality, and operations teams. * Support ... deviations, change controls, punch list resolution, and compliance activities. * Participate in FAT ...

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How much do validation engineer jobs pay per hour?

As of Jul 1, 2026, the average hourly pay for validation engineer in Raleigh, NC is $50.54, according to ZipRecruiter salary data. Most workers in this role earn between $38.32 and $61.44 per hour, depending on experience, location, and employer.

What Is a Validation Engineer?

A validation engineer is responsible for testing equipment and electrical systems used in the manufacturing process. As a validation engineer, your primary duty is to work with the other members of the validation team to ensure that these systems measure up to company and industry standards. Skills needed for a validation engineer job include the ability to accurately test, measure, and calibrate manufacturing equipment for maximum efficiency and quality.

What is the difference between Validation Engineer vs Quality Assurance Engineer?

AspectValidation EngineerQuality Assurance Engineer
CertificationsGMP, ISO, Six SigmaISO, Six Sigma, CQA
Work EnvironmentRegulated industries like pharma, biotech, medical devicesManufacturing, software, and product development
Primary FocusEnsuring products meet specifications through validation processesPreventing defects through process and system improvements
Common UsageRegulatory compliance, validation protocolsProcess audits, quality systems

Validation Engineers focus on verifying that products and processes meet regulatory standards through validation protocols, especially in regulated industries. Quality Assurance Engineers concentrate on maintaining overall product quality by implementing and auditing quality systems. While both roles aim to ensure product safety and efficacy, Validation Engineers are more involved in validation activities, whereas QA Engineers focus on process improvement and defect prevention.

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

To thrive as a Validation Engineer, you need a solid background in engineering, quality assurance, and regulatory compliance, typically backed by a degree in engineering or a related field. Familiarity with validation protocols, statistical analysis tools, and industry-specific regulations such as FDA, GMP, or ISO standards is essential. Strong analytical thinking, attention to detail, and effective communication set top performers apart in this role. These skills ensure that products and processes meet stringent quality and safety standards, minimizing risks and ensuring regulatory approval.

What are some common challenges Validation Engineers face when working cross-functionally with other departments?

Validation Engineers frequently collaborate with teams such as manufacturing, quality assurance, and research & development. One common challenge is aligning differing priorities and timelines between departments, which can sometimes delay validation projects. Effective communication skills and flexibility are crucial to navigating these cross-functional interactions, ensuring that all regulatory and quality requirements are met without hindering production schedules. Building strong working relationships and proactively addressing potential concerns can help Validation Engineers facilitate smoother project execution.

What are Validation Engineers?

Validation Engineers are professionals responsible for ensuring that systems, processes, or equipment meet regulatory standards and function as intended. They typically work in industries such as pharmaceuticals, biotechnology, manufacturing, and medical devices. Their duties involve creating validation protocols, conducting tests, analyzing data, and documenting results to ensure compliance with industry regulations and quality standards. Validation Engineers play a critical role in maintaining product safety and efficacy, as well as helping companies pass audits and inspections.
More about Validation Engineer jobs
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Validation Engineer jobs near you
"cleaning validation"

"cleaning validation"

Intellectt INC

Holly Springs, NC • On-site

Contractor

Posted 18 days ago

Be an early applicant

Job description

Role:CQV Engineer – Cleaning Validation 
Location: Holly Springs, NC 
Key Responsibilities:

  • Execute and document cleaning validation protocols per FDA/ICH guidelines (ALCOA principles).

  • Apply expertise with bioreactors, autoclaves, parts washers, and filling machines.

  • Perform MACO calculations to support cleaning limit determinations.

  • Use Kneat for electronic validation documentation and tracking.

  • Work on fill-finish processes and equipment validation.

  • Coordinate with cross-functional teams including manufacturing, QC, QA, and engineering.

  • Review and contribute to analytical method development related to cleaning and residue testing.

Required Skills & Experience:

  • 5–8+ years in CQV/Validation within biologics/pharmaceutical manufacturing.

  • Strong understanding of FDA cGMP, ALCOA, and data integrity principles.

  • Experience with Kneat or other electronic validation tools.

  • Familiarity with MACO, analytical methods, and technical documentation.

  • Must have experience with fill-finish processes, bioreactors, and cleaning equipment.