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Process Validation Jobs (NOW HIRING)

Peregrine Team

Validation Engineer

Philadelphia, PA · On-site

Peregrine Team is hiring a Validation Engineer to support equipment and process validation within a regulated pharmaceutical environment. This role ensures compliance with regulatory standards and ...

Intellectt INC

Validation Lead

Raleigh, NC · On-site

The role will be responsible for leading equipment qualification, process validation, cleaning validation, computerized system validation support, and compliance documentation. The Validation Lead ...

Centstone

Validation Engineer (CQV)

Lexington, KY · On-site

Key Responsibilities • Execute CQV activities for utilities, process equipment, and process validation in a GMP environment • Develop and complete CQV lifecycle documentation including URS/FRS ...

Legend Biotech US

Validation Specialist

Raritan, NJ · On-site

$120K/yr

Control Aseptic process validation and particle runs from protocol generation, training execution oversite and reporting. Support equipment process qualification and ensure consistency with process ...

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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 Engineer, Advanced Manufacturing Engineering

Process Validation Engineer, Advanced Manufacturing Engineering

Ambu

Noblesville, IN • On-site

Full-time

Posted 22 days ago

Job description

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Process Validation Engineer, Advanced Manufacturing Engineering
City: Noblesville
Country/Region: United States
State: Indiana
Business Area: Production
Department: Production, NV - IE
Employment Type: Full-time
Req ID: 9766
Ambu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This role will be based out of the Ambu America's Center of Excellence located at the Noblesville, Indiana manufacturing facility. The role has overall responsibility for the Advanced Manufacturing Engineering functions of both the Noblesville, IN and the Juarez, MX manufacturing sites. The expected travel for this role is up to 50%.
Objective:
The Process Validation Engineer leads the validation aspects of Automation and Equipment Capital projects, process improvements, supports the development of automated solutions, is responsible of the validation of new equipment installation, ensuring seamless process transfer and readiness to production.
Responsibilities and Essential Functions:
Compliance and Validation:
  • Validation Documents preparation and execution, to ensure all automated systems and/or process improvements are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards, before release to production.
  • Evaluation of validation strategy to ensure quick and compliant transfer of processes and equipment to production.
  • Maintenance of the Agile documents related to processes and equipment, like SOP, flow charts, electrical drawings, 2D/3D drawings, equipment parameter list (CP), equipment logic program (LCP).
  • Complying with FDA QSR, ISO 13485, and relevant product-specific regulations (e.g., IEC 60601, ISO 14971).
  • Operational & Regulatory Excellence

Automation & Smart Manufacturing:
  • Assist to the design and implementation of automated manufacturing and assembly systems (e.g., robotics, PLCs, vision systems, motion control) to support precision, repeatability, and compliance.
  • Assist to automation and equipment capital projects from concept to installation and validation.
  • The role requires to be "hands on", on the process and equipment, when needed.

Operational Excellence:
  • Champion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations.

Authorities:
  • Ability to approve validation protocols, test plans, and reports.
  • Authority to sign off on equipment and process validation documentation.
  • Determine corrective and preventive actions (CAPA) related to validation findings.

Work Environment:
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.
Qualifications:
  • Bachelor's degree in related field and 3 - 5 years of relevant work experience.
  • Five years' experience working in the medical device field.
  • Strong background in medical device process validation, and regulatory compliance.
  • Ability to complete complex reports and correspondence.
  • Must be able to speak, read, write and understand English.
  • Bilingual in Spanish is preferred.

Ambu Provided Training within the first six months:
  • Agile, Change Control System
  • Movex, ERP System
  • Medius, Procurement System
  • Validation Training

About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.
For more information, please visit ambu.com or follow us on LinkedIn.
About Ambu
Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.
For more information, please visit ambu.com or follow us on LinkedIn.
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About Ambu

Sourced by ZipRecruiter

Industry

Medical equipment and supplies manufacturing

Company size

501 - 1,000 Employees

Headquarters location

Noblesville, IN, US

Year founded

1937

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