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Validation Engineer Jobs in Raleigh, NC (NOW HIRING)

Eupry

Validation Team Manager (Raleigh, NC)

Raleigh, NC · On-site

Join us at Eupry and take the helm of a talented group of validation engineers who are delivering industry-leading CQV (Commissioning, Qualification, and Validation) services to global pharmaceutical ...

Eupry

Validation Team Manager (Raleigh, NC)

Raleigh, NC · On-site

Join us at Eupry and take the helm of a talented group of validation engineers who are delivering industry-leading CQV (Commissioning, Qualification, and Validation) services to global pharmaceutical ...

Intellectt INC

CQV Engineer

Holly Springs, NC · On-site

CQV Engineer Location: Holly Springs, NC Duration: Long-Term Contract Summary: We are hiring ... Candidates should have strong experience in commissioning, qualification, validation, and startup ...

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How much do validation engineer jobs pay per hour?

As of Jun 7, 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 jobs make $3,000 a month without a degree?

Validation engineers typically require a degree, but similar roles in fields like sales, customer service, or skilled trades can pay around $3,000 monthly without a degree. Jobs such as commercial drivers, certain technical support roles, or entry-level trades may also meet this income level with relevant experience or certifications. Success in these roles often depends on skills, certifications, and experience rather than formal education.

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.
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Validation Engineer jobs near you
6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

6385- Senior CSV/CQV Engineer / Senior Validation Engineer 2

Verista, Inc.

Durham, NC • On-site

Other

Posted 2 days ago

Job description

Position Summary

The CSV/CQV Engineer will support the commissioning, qualification, and validation of process equipment, utilities, facilities, and PAT systems. This role is responsible for all computerized system validation (CSV) and data integrity (DI) activities, working under the direction of the Validation Lead and alongside the CQV team.

General CSV Skills

  • Familiarity with global standards for computerized systems and data integrity.
  • Ability to classify systems as "simple" or "complex" using riskbased criteria to rightsize validation effort.
  • Experience authoring CSV deliverables: URS/FDS/DDS review, risk assessments, test protocols (IQ/OQ), and summary reports.
  • Supplier assessment execution for OEMprovided computerized systems.
  • Data integrity assessment using ALCOA+ principles, including audit trail, user roles, time sync (NTP), backup/restore, and archival.

ProjectSpecific CSV Responsibilities

CSV Deliverables

  • Author Data Integrity Assessments for each Direct Impact computerized system, defining roles/privileges, and confirming electronic records handling.
  • Assess and document how PAT result data integrates with the paperbased manufacturing batch record (MBR) interface, ensuring data integrity at the point of data transfer.
  • Perform supplier assessments for major OEM systems and PAT instruments.
  • Author configuration specifications for computerized systems where client templates are available or where vendor documentation is insufficient.
  • Write CSV sections within IQ/OQ protocols - access control, audit trail verification, time sync (NTP), backup/restore, and data flow tests.
  • Develop data flow diagrams for critical integrations:
  • Execute IQ/OQ CSV test scripts, including; User role and access control, Audit trail review, Time synchronization, Backup and restore, and Data flow and accuracy 
  • PAT integration testing
  • Document any deviations discovered during CSV testing, perform impact assessment, and track CAPAs to closure.

Required Qualifications

  • Bachelor's degree in engineering, computer science, or related field.
  • Minimum 5 years of CSV experience in GMP pharmaceutical or biotech environments.
  • Proven experience with equipmentlevel PLC/HMI validation (OEM systems) and historian connectivity.
  • Handson experience with PAT instrument integration (e.g., NIR, moisture analyzers) is a strong plus.
  • Must be local in or around RTP, must be able to work on site 100%.

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