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Process Validation Jobs (NOW HIRING)

Danaher

Senior Engineer, Process Validation

Boston, MA · 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 ...

Danaher

Senior Engineer, Process Validation

$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

Dallas, 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 ...

Danaher

Senior Engineer, Process Validation

Sunnyvale, CA · 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 the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Entry-level positions may start lower, while experienced engineers with specialized skills in hardware description languages and verification tools can earn higher salaries.

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 4 types of process validation?

Process validation in the context of process validation involves four main types: prospective validation, concurrent validation, retrospective validation, and revalidation. Prospective validation is performed before a process is in routine production, concurrent validation occurs during initial production runs, retrospective validation reviews historical data to confirm process consistency, and revalidation is conducted when changes are made to the process. These types help ensure that manufacturing processes consistently produce quality products and comply with regulatory standards.

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 does process validation do?

Process validation is a key responsibility in process validation roles, ensuring that manufacturing processes consistently produce products meeting quality standards. It involves designing, testing, and documenting processes to confirm they operate reliably and within specified parameters, often using tools like statistical analysis and validation protocols. This helps maintain product quality, compliance, and reduces the risk of defects or failures.
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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 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 Specialist

Process Validation Specialist

Mentor Technical Group

Juncos, PR • On-site

Full-time

Posted 5 days ago

Job description

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
  • Plan, coordinate, and execute validation activities for parenteral and aseptic manufacturing processes.
  • Prepare, review, and approve validation protocols, reports, and related documentation.
  • Perform Aseptic Process Validation, including Environmental Monitoring, Performance Qualifications, Environmental Characterizations, and Airflow Visualization (Smoke Tests).
  • Execute validation activities inside clean rooms, following GMP, SOPs, and regulatory requirements.
  • Collaborate with QA/QC, production, and engineering teams to ensure validation timelines are met and deviations are addressed promptly.
  • Monitor progress of validation projects, identify potential delays, and propose corrective actions.
  • Maintain accurate records of all validation activities, including schedules, results, and approvals.
  • Support continuous improvement initiatives related to validation processes and compliance.

Qualifications / Requirements / Knowledge / Education / Skills:
  • Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Engineering, or related field.
  • Minimum of 5-10 years' experience in validation activities in FDA-regulated environments, preferably in parenteral or aseptic manufacturing.
  • Strong experience in Aseptic Process Validation, Aseptic Techniques, Environmental Monitoring, Performance Qualifications, Environmental Characterizations, and Airflow Visualization (Smoke Tests).
  • Experience writing protocols, validation reports, and executing procedures inside clean rooms.
  • Knowledge of GMP, FDA regulations, and quality systems.
  • Proficiency in English; additional language skills are a plus.
  • Strong analytical, organizational, and problem-solving skills.
  • Excellent communication skills and ability to collaborate effectively across multidisciplinary teams.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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