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Process Validation Jobs (NOW HIRING)

INCOG

Senior Process Validation Engineer

Fishers, IN · On-site

$97K - $125K/yr

TSMS - Senior Process Validation Engineer The Senior Process Validation Engineer - Technical Services and Manufacturing Sciences (TSMS) will be responsible for leading all facets of Process ...

AMRESCO

Process & Validation Engineer I

Devens, MA · On-site

$52K - $83K/yr

They develop and execute validation of equipment and processes, create necessary documentation and aides in communication to personnel, and serve as a resource to site associates and coordination of ...

Avantor Inc.

Process & Validation Engineer I

Devens, MA · On-site

$52K - $83K/yr

They develop and execute validation of equipment and processes, create necessary documentation and aides in communication to personnel, and serve as a resource to site associates and coordination of ...

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How much do process validation jobs pay per hour?

As of Jun 11, 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.

More about Process Validation jobs
What cities are hiring for Process Validation jobs? Cities with the most Process Validation job openings:
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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 Associate / Engineer

Process Validation Associate / Engineer

Krystal Biotech

Pittsburgh, PA • On-site

Full-time

Posted 23 days ago

Job description

About Krystal Bio:
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.
Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient's end-to-end experience.
Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.
Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.
Job Description Summary:
Krystal Biotech is seeking a highly motivated Process Validation Associate (1+ years' experience) or Engineer (3+ years' experience) to support process validation planning, design, and execution. This person will be responsible for risk assessments, process improvements, investigations, and other projects. They will also play a pivotal role in technology transfer and ensuring processes transition properly from site to site.
Primary Responsibilities:
  • Partner with Process Development and Manufacturing to ensure upstream and downstream processes are well controlled.
  • Apply QbD and traditional process validation principles to existing and new gene therapy products.
  • Perform and document risk assessments to capture existing process knowledge and to identify gaps.
  • Perform experiments (bench scale and manufacturing scale) to close gaps in process understanding and to support process development.
  • Troubleshoot process and equipment issues to help ensure efficiencies in processes.
  • Help implement a continuous improvement mindset to processes and departments.
  • Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
  • Work on development of new manufacturing facility to ensure proper transfer of technology and processes.
  • Work with CMC counterparts to draft materials intended for the agency review.

Minimum Qualifications & Desired Competencies:
  • Bachelors' Degree in Chemical Engineering, Biomedical Engineering, or related
  • Relevant validation and/or engineering experience in the Biotech or Pharmaceutical industry (1+ yr for Associate, 3+ yr for Engineer level)
  • Background that includes knowledge/experience in GMP, GLP, and statistics
  • Strong knowledge of GMP and ICH requirements and QbD
  • Prior experience in the gene therapy field is desired
  • Must be a self-starter and capable of working with minimal oversight
  • Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately
  • Excellent oral and written communication skills

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.

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