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Process Validation Jobs in North Carolina (NOW HIRING)

Kaygen Inc.

Engineer3, Process Validation

Durham, NC · On-site

Engineer3, Process Validation Location: Durham NC Duration: 12-month contract On site, 5 days at week, Industrial Engineer This position is responsible for implementing and sustaining the Operational ...

Valspec

Process Validation Engineer

Raleigh, NC

$70 - $80/hr

Valspec--a global provider of system validation and lifecycle services--provides commissioning and ... Process Engineer -- Upstream / Downstream / Clean Utilities (Consultant) -- Contract Engagement:

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 ...

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 ...

FUJIFILM Biotechnologies

Position OverviewThe Senior Engineer or Scientist of Process Validation ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and ...

Lancesoft

Process Validation Engineer3

Durham, NC · On-site

$52 - $54.85/hr

... validation processes. • Ability to manage multiple priorities and drive sustainable business results through cross-functional collaboration. Core Leadership Expectations • Lead by example in ...

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Process Validation information

See North Carolina salary details

$7

$35

$62

How much do process validation jobs pay per hour?

As of Aug 10, 2026, the average hourly pay for process validation in North Carolina is $35.93, according to ZipRecruiter salary data. Most workers in this role earn between $20.96 and $46.73 per hour, depending on experience, location, and employer.

What is process validation?

Process validation is a documented procedure used in industries, especially pharmaceuticals and manufacturing, to ensure that a process consistently produces a product meeting its predetermined specifications and quality attributes. It involves planning, conducting, and analyzing studies that provide evidence the process is reliable and reproducible. Regulatory agencies like the FDA require process validation to guarantee product safety and efficacy. Process validation typically includes design, qualification, and continued monitoring stages. This ensures that any variations in the process do not affect the final product's quality.

What are some common challenges faced by professionals in process validation, and how can they be addressed?

Professionals in Process Validation often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and resolving unexpected deviations during validation runs. Effective communication with cross-functional teams—such as Quality Assurance, Manufacturing, and R&D—can help address these issues quickly. Staying proactive with documentation, maintaining a robust risk assessment process, and continually updating knowledge on industry regulations are key strategies to overcoming these challenges and ensuring successful validation outcomes.

What are the key skills and qualifications needed to thrive as a process validation specialist, and why are they important?

To thrive as a Process Validation Specialist, you need a strong background in engineering, life sciences, or a related field, along with expertise in validation protocols and regulatory guidelines such as GMP. Familiarity with validation software, data analysis tools, and documentation systems like LIMS is typically required, and certifications such as Six Sigma or ASQ may be advantageous. Attention to detail, analytical thinking, and effective communication are crucial soft skills for this role. These skills ensure that manufacturing processes consistently produce products that meet quality standards and regulatory compliance, which is essential for patient safety and product efficacy.

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

AspectProcess ValidationQuality Assurance Specialist
CredentialsGMP, ISO certifications, technical trainingGMP, ISO certifications, auditing training
Work EnvironmentManufacturing, pharmaceutical, biotech facilitiesQuality departments, manufacturing sites
Employer & Industry UsageUsed in regulated industries to ensure process consistencyEnsures product quality through audits and compliance

Process Validation focuses on confirming that manufacturing processes consistently produce quality products, while Quality Assurance Specialists oversee overall quality systems, audits, and compliance. Both roles are essential in regulated industries but serve different functions in maintaining product integrity.

What skills are needed for process validation?

Process validation professionals need strong analytical skills, attention to detail, and knowledge of manufacturing processes and quality systems. Familiarity with regulatory requirements such as GMP, validation protocols, and documentation practices is essential. Proficiency with data analysis tools and good communication skills are also important for successful validation activities.
What are popular job titles related to Process Validation jobs in North Carolina? For Process Validation jobs in North Carolina, the most frequently searched job titles are:
What job categories do people searching Process Validation jobs in North Carolina look for? The top searched job categories for Process Validation jobs in North Carolina are:
Process Validation jobs near you
Infographic showing various Process Validation job openings in North Carolina as of August 2026, with employment types broken down into 67% Full Time, and 33% Contract. Highlights an 100% In-person job distribution, with an average salary of $74,737 per year, or $35.9 per hour.

Process Validation Engineer

Stark Pharma Solutions Inc

Concord, NC • On-site

Contractor

Re-posted 2 days ago

Job description

Position: Process Validation Engineer
Location: North Carolina
Duration: Long Term

Job Overview

We are seeking a Process Validation Engineer to support process validation activities for sterile pharmaceutical manufacturing projects. The role involves developing and executing process validation strategies, supporting technology transfer activities, leading Process Performance Qualification (PPQ) studies, and ensuring compliance with cGMP and regulatory requirements. The ideal candidate should have experience working in sterile manufacturing environments and collaborating with cross-functional teams to support validation and qualification activities.

Key Responsibilities

• Develop and execute process validation strategies.
• Lead Process Performance Qualification (PPQ) activities.
• Support Technology Transfer (Tech Transfer) projects.
• Coordinate aseptic media fill and revalidation activities.
• Conduct smoke studies and qualification activities for automated visual inspection systems.
• Collaborate with cross-functional teams to ensure compliance with cGMP and regulatory requirements.

Required Qualifications

• 5+ years of experience in Process Validation within the pharmaceutical industry.
• Experience working in a sterile manufacturing environment.
• Strong experience with Process Validation, Tech Transfer, and PPQ.
• Experience supporting aseptic media fills and smoke studies.
• Knowledge of cGMP and pharmaceutical regulatory requirements.
• Strong communication, organizational, and cross-functional collaboration skills.