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Process Validation Jobs (NOW HIRING)

FITS LLC

Process Validation Engineer

Dorado, PR · On-site

For Process Validation services in the manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor's in Engineering with five (5) years of experience in Process Validation activities ...

Micropulse, Inc.

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Process Validation Engineer

Columbia City, IN · On-site

$20 - $25/hr

* Perform verification and validation testing activities on processes used in medical device manufacturing * Aid in the establishment of new processes and the parameters associated with the processes

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How much do process validation jobs pay per hour?

As of Jun 10, 2026, the average hourly pay for process validation 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 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.

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Process Validation jobs near you
Infographic showing various Process Validation job openings in the United States as of June 2026, with employment types broken down into 2% Locum Tenens, 23% Full Time, 72% Part Time, 2% Temporary, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $82,237 per year, or $39.5 per hour.

Process Validation Engineer

Stark Pharma Solutions Inc

Concord, NC • On-site

Contractor

Posted yesterday

Job description

Hi,

My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

You can also follow Stark Pharma Solutions on LinkedIn for the latest job updates:

https://www.linkedin.com/company/99455976/

Role: Process Validation Engineer

Location: North Carolina

Position Overview

We are seeking an experienced Process Validation Engineer to support multiple pharmaceutical manufacturing projects, with a primary focus on aseptic filling operations and pre-filled syringe (PFS) manufacturing. This role will be responsible for developing and executing validation strategies, supporting tech transfer initiatives, and ensuring compliant process implementation across new and existing manufacturing lines.

The ideal candidate will have strong expertise in process validation, aseptic processing, PPQ execution, media fills, smoke studies, and cGMP-regulated pharmaceutical manufacturing environments.

Key Responsibilities

  • Develop and execute process validation strategies for new and existing fill-finish manufacturing lines.
  • Lead Process Performance Qualification (PPQ) activities to demonstrate process consistency, reliability, and regulatory compliance.
  • Support revalidation activities for pre-filled syringe (PFS) filling lines and associated manufacturing processes.
  • Coordinate, execute, and evaluate aseptic media fill studies to ensure process integrity and contamination control.
  • Plan and conduct smoke studies to verify airflow patterns and aseptic processing conditions.
  • Support technology transfer projects by implementing manufacturing processes across new and existing production lines.
  • Collaborate with Manufacturing, Quality, Engineering, Validation, and external stakeholders to ensure successful project execution.
  • Participate in risk assessments, protocol development, execution, deviation management, and final reporting.
  • Support qualification activities for automated visual inspection systems and aseptic processing equipment.
  • Ensure all validation documentation complies with cGMP, FDA, and regulatory requirements.

Required Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
  • Experience in pharmaceutical process validation within aseptic manufacturing environments.
  • Hands-on experience with:
  • Process Validation
  • Process Performance Qualification (PPQ)
  • Aseptic Media Fills
  • Smoke Studies
  • Technology Transfer
  • Experience supporting pre-filled syringe (PFS) manufacturing operations.
  • Strong understanding of cGMP regulations and validation lifecycle activities.
  • Excellent communication and cross-functional collaboration skills.