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Process Validation Jobs (NOW HIRING)

Agilent

Process Validation Engineer

Frederick, CO

$105K - $164K/yr

As a Process Validation Engineer within the Process Validation team of Agilent's Advanced Therapeutics Division (ATD), the candidate will be responsible for executing process validation activities of ...

Agilent

Process Validation Engineer

Boulder, CO

$105K - $164K/yr

As a Process Validation Engineer within the Process Validation team of Agilent's Advanced Therapeutics Division (ATD), the candidate will be responsible for executing process validation activities of ...

Agilent

Process Validation Engineer

Frederick, CO · On-site

$105K - $164K/yr

As a Process Validation Engineer within the Process Validation team of Agilent's Advanced Therapeutics Division (ATD), the candidate will be responsible for executing process validation activities of ...

CYNET SYSTEMS

Process Validation Engineer

Northridge, CA · On-site

$35 - $40/hr

Plan, execute, and document process validation activities. * Develop and review validation protocols, reports, and related documentation. * Perform IQ, OQ, and PQ for manufacturing equipment and ...

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Micropulse, Inc.

Be Seen First

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

Danaher

Senior Engineer, Process Validation

Houston, TX · 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 ...

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How much do process validation jobs pay per hour?

As of Jul 1, 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 states have the most Process Validation jobs? States with the most job openings for Process Validation jobs include:
What job categories do people searching Process Validation jobs look for? The top searched job categories for Process Validation jobs are:
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 96% Full Time, and 4% Contract. 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

Process Validation Engineer

Agilent

Frederick, CO

$105K - $164K/yr

Full-time

Posted 6 days ago

Agilent Technologies rating

8.1

Company rating: 8.1 out of 10

Based on 40 frontline employees who took The Breakroom Quiz

110th of 527 rated manufacturers

Job description

Job Description

Agilent Technologies Advanced Therapeutics Division (previously Nucleic Acids Solutions Division) is looking for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado.


As a Process Validation Engineer within the Process Validation team of Agilent's Advanced Therapeutics Division (ATD), the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include:

Control Strategies: Contribute knowledge and technical expertise to the development and refinement of manufacturing control strategies for oligonucleotide unit operations (examples: synthesis, deprotection, ultrafiltration, purification, annealing, concentration, lyophilization).


Stage 1 Assessments/Evaluations: Identify, assess, mitigate, and communicate process risks that may impact product quality, process performance, or regulatory compliance. Prepare and/or review process validation documentation including risk assessments, characterization plans/reports, technical assessments, control strategies, protocols, and summary reports.


Stage 1 Characterization: Perform or support process development studies. May include planning, executing, and analyzing Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments to support design space understanding and process validation as they relate to oligonucleotide upstream and downstream process operations.


Experiment Execution: Support laboratory scale experiment execution (occasional) to assess process risks and/or demonstrate robustness of process conditions. This may include set-up and operation of laboratory equipment. Document bench experiments in accordance with good documentation practices (GDP), analyze results, summarize findings, and provide recommendations based on outcomes.


Stage 2 CGMP Protocol Execution: Lead and/or support execution of process validation studies in a CGMP manufacturing setting.


PPQ and Commercial Support: Evaluate change controls associated with Process Performance Qualification (PPQ) or commercial processes. Evaluate process validation impact of nonconformances. Review commercial batch records to ensure alignment with Process Control Strategies.


Stage 3 CPV: Support continued process verification, which may include but is not limited to leading Continued Process Verification (CPV) plans, authoring CPV reports, and reviewing Product Quality Reports.


Lifecycle: Supports all areas of process validation from FDAs Product Lifecycle's Stages 1, 2, and 3.

Communication: Provide process validation-related updates to clients and project teams in the form of slides, memos, and reports.

Qualifications

  • Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field.

  • 8+ years of experience in a GMP API setting.

  • Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process.

  • Knowledge and experience in process validation studies at the bench and in a plant setting.

  • Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP (or similar) software is highly desirable.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least July 1, 2026 or until the job is no longer posted.The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: NoShift: DayDuration: No End DateJob Function: R&D

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