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Process Validation Engineer Jobs (NOW HIRING)

INCOG

Process Validation Engineer

Fishers, IN

TSMS - Process Validation Engineer The Technical Services and Manufacturing Sciences (TSMS) Process Validation Engineer will be responsible for supporting all facets of Process Validation, GMP Floor ...

Valspec

Process Validation Engineer

Raleigh, NC

Process Engineer (Process Validation / PPQ Readiness) Location: Sanford, NC (Onsite) Type: Contract | Full-Time (40 Hours/Week) Duration: Approximately 9 Months Position Summary Our client is seeking ...

Valspec

Process Validation Engineer

Sanford, NC · On-site

Process Engineer (Process Validation / PPQ Readiness) Location: Sanford, NC (Onsite) Type: Contract | Full-Time (40 Hours/Week) Duration: Approximately 9 Months Position Summary Our client is seeking ...

Valspec

Process Validation Engineer

Durham, NC · On-site

Process Engineer (Process Validation / PPQ Readiness) Location: Sanford, NC (Onsite) Type: Contract | Full-Time (40 Hours/Week) Duration: Approximately 9 Months Position Summary Our client is seeking ...

Valspec

Process Validation Engineer

Holly Springs, NC · On-site

Process Engineer (Process Validation / PPQ Readiness) Location: Sanford, NC (Onsite) Type: Contract | Full-Time (40 Hours/Week) Duration: Approximately 9 Months Position Summary Our client is seeking ...

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How much do process validation engineer jobs pay per hour?

As of Aug 31, 2026, the average hourly pay for process validation engineer in the United States is $39.54, according to ZipRecruiter salary data. Most workers in this role earn between $23.08 and $51.44 per hour, depending on experience, location, and employer.

What is a process validation engineer?

Process Validation Engineers are professionals responsible for ensuring that manufacturing processes consistently produce products that meet predetermined quality standards. They design, execute, and document validation protocols to verify that equipment, systems, and processes operate effectively and efficiently. These engineers play a crucial role in regulated industries such as pharmaceuticals, biotechnology, and medical devices, where compliance with industry standards and regulatory requirements is essential. Their work helps to minimize risks, ensure product safety, and maintain regulatory compliance.

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

To thrive as a Process Validation Engineer, you need a solid background in engineering or life sciences, a thorough understanding of validation protocols, and knowledge of industry regulations such as GMP. Experience with validation software, statistical analysis tools, and familiarity with regulatory documentation systems are typically required. Strong analytical thinking, attention to detail, and effective communication skills help you resolve issues and coordinate cross-functional teams. These skills and qualities are essential to ensure processes are compliant, efficient, and produce high-quality, safe products.

What are some common challenges faced by process validation engineers during product scale-up?

Process Validation Engineers often encounter challenges when scaling up products from development to full-scale manufacturing. These can include ensuring process consistency, managing variations in equipment or raw materials, and troubleshooting unexpected deviations that may not have surfaced during small-scale trials. Effective communication with cross-functional teams—such as quality assurance, production, and R&D—is essential to quickly address issues and maintain compliance with regulatory requirements. Being proactive and detail-oriented helps navigate these complexities and ensures successful validation outcomes.

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

AspectProcess Validation EngineerQuality Assurance Engineer
Primary FocusValidating manufacturing processes to ensure product quality and complianceDeveloping and implementing quality systems and procedures to prevent defects
CertificationsGMP, ISO, Six Sigma often preferredISO, Six Sigma, CQE certifications common
Work EnvironmentManufacturing, pharmaceutical, biotech facilitiesQuality departments across various industries
Key ResponsibilitiesProcess validation, protocol development, troubleshootingAudits, quality audits, process improvements

While both roles aim to ensure product quality, the Process Validation Engineer primarily focuses on validating manufacturing processes, whereas the Quality Assurance Engineer oversees overall quality systems and compliance. Both roles often collaborate but serve distinct functions within the quality management framework.

Do process validation engineers make good money?

Process validation engineers typically earn competitive salaries that vary by industry, experience, and location. They often have specialized skills in quality assurance, regulatory compliance, and validation tools, which can lead to higher compensation levels. Overall, the role is considered well-paying within manufacturing, pharmaceutical, and biotech sectors.

What does a process validation engineer do?

A process validation engineer is responsible for developing, executing, and documenting validation protocols to ensure manufacturing processes meet quality and regulatory standards. They analyze process data, identify risks, and implement improvements using tools like statistical analysis and validation software. Their work helps ensure products are consistently produced to specifications and comply with industry regulations.
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Process Validation Engineer jobs near you
Infographic showing various Process Validation Engineer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 16% Part Time, 3% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $82,237 per year, or $39.5 per hour.

Process Validation Engineer

Raleigh, NC • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted 2 days ago

Job description

Position: Process Validation Engineer

Location: North Carolina (Onsite)
Duration: Long-Term Contract

Job Overview

We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance.

Key Responsibilities

  • Develop and execute process validation strategies for new and existing sterile manufacturing processes.
  • Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
  • Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
  • Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
  • Perform process revalidation activities and maintain validated manufacturing processes.
  • Support smoke studies and qualification activities for automated visual inspection systems.
  • Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
  • Prepare and review validation protocols, reports, risk assessments, and technical documentation.
  • Ensure compliance with cGMP, FDA regulations, and industry best practices.
  • Provide technical support for investigations, process improvements, and continuous improvement initiatives.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or a related discipline.
  • Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
  • Hands-on experience with Technology Transfer and PPQ execution.
  • Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
  • Experience supporting smoke studies and qualification activities.
  • Excellent technical writing, communication, and cross-functional collaboration skills.
  • Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.