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

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

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 ...

Senior Engineer

Apex, NC · On-site

$79K - $109K/yr

The Senior R&D Engineer for Telecom Outside Plant (OSP) New Product Development plays a key technical leadership role in the conception, validation, and commercialization of next-generation telecom ...

Senior Engineer

Apex, NC · On-site

$79K - $109K/yr

The Senior R&D Engineer for Telecom Outside Plant (OSP) New Product Development plays a key technical leadership role in the conception, validation, and commercialization of next‑generation telecom ...

Senior Firmware Engineer

Durham, NC · On-site

$115K - $152K/yr

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

Senior Automation Engineer

Durham, NC

$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.

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.

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 ...

We're looking for a Senior Systems Engineer who wants true technical ownership - someone ready to ... Partner with quality, validation, supply chain, and manufacturing to ensure designs are buildable ...

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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 Jun 16, 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 are Sr Validation Engineers?

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, and why are they important?

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 cities near Raleigh, NC are hiring for Sr Validation Engineer jobs? Cities near Raleigh, NC with the most Sr Validation Engineer job openings:
Infographic showing various Sr Validation Engineer job openings in Raleigh, NC as of June 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $130,965 per year, or $63 per hour.

Sr Engineer, PD Process Validation & Business - Holly Springs, NC

National Guard Employment Network

Holly Springs, NC • On-site

$75K - $100K/yr

Full-time

Posted 20 days ago


Job description

Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
What you will do
Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen's FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes development, support, and execution of process validation. The role will be responsible for ensuring process validation activities are performed in a consistent and controlled manner to support manufacture of drug substances. In addition, the role will be responsible for driving PD business strategy activities and providing cross-functional tech transfer support.
Lead the development of Process Validation/Process Performance Qualification strategy for New Products, ensuring alignment with regulatory guidelines and industry standards.
Apply a fundamental understanding of Upstream (Cell Culture) and Downstream (Purification) bioprocessing to support process validation, technology transfer support, and plant start-up
Lead the execution of validation projects and/or protocols and the collection of data to ensure completion of process validation activities.
Provide cross-functional process monitoring support as needed
Provide guidance for the generation, resolution and closure of deviations.
Lead ANC PD business strategy activities to improve network practice, develop digital tools, and optimize the ANC PD business operations
Ensure safety and compliance of process development activities
Provide process validation floor process support as required
Lead process validation support for regulatory filing, inspection, and other CMC activities
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications.
Basic Qualifications:
  • High school diploma / GED and 10 years of biologics process development, process engineering, or process validation experience OR
  • Associate's degree and 8 years of biologics process development, process engineering, or process validation experience OR
  • Bachelor's degree and 4 years of biologics process development, process engineering, or process validation experience OR
  • Master's degree and 2 years of biologics process development, process engineering, or process validation experience OR
  • Doctorate degree

Preferred Qualifications:
  • 5+ years of experience in a process validation or downstream (purification) role supporting biopharmaceutical manufacturing processes within regulated environments (i.e., cGMP)
  • Strong and in-depth expertise of the operation of upstream and downstream manufacturing processes
  • Validation experience with biopharmaceutical processes including PPQ, master plans, protocols, and reports
  • Independently motivated with successful ability to multi-task and work in teams
  • Demonstrated leadership skills and decision-making experience
  • Experience in process scale-up, technology transfers, EBRs, deviation, CAPA, and change control processes.
  • Excellent oral and verbal communication skills, interact effectively with diverse internal and external stakeholders

Salary Range
115,494.60USD -156,257.40 USD