ZipRecruiter

Log In

1

Process Validation Engineer Jobs (NOW HIRING)

INCOG

Senior Process Validation Engineer

Fishers, IN

$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 ...

FITS LLC

Process Validation Engineer - 134

Villalba, PR · On-site

Process Validation, Equipment IQ, and Computer software validation knowledge * No sterile package ... Guide engineers regarding design concepts and specification requirements to best utilize equipment ...

AMRESCO

Process & Validation Engineer I

Devens, MA · On-site

$52K - $83K/yr

The Process Engineer implements process improvements to meet quality standards, designs and conducts feasibility studies, and solves problems. They develop and execute validation of equipment and ...

Avantor Inc.

Process & Validation Engineer I

Devens, MA · On-site

$52K - $83K/yr

The Process Engineer implements process improvements to meet quality standards, designs and conducts feasibility studies, and solves problems. They develop and execute validation of equipment and ...

RD Partners

Validation Engineer

Tucson, AZ · On-site

$39 - $42/hr

Your main responsibilities as a Validation Engineer: · Develop, write, review, and execute process validation/process verification protocols and reports. · Conduct risk assessments and develop ...

Dawar Consulting, Inc.

Validation Engineer

Tucson, AZ

$39 - $42/hr

This on-site role focuses on process validation activities to ensure compliance with FDA, ISO, cGMP ... Bachelor's degree in Engineering, Life Sciences, or related field * 1-3 years of experience in ...

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 ...

Validation & Engineering Group, Inc

PR · On-site

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Perform process validation activities related to sterile manufacturing, including media fills (APS)

Intellectt INC

Validation Engineer

North Haven, CT · On-site

Lead and execute equipment and process validations (IQ/OQ/PQ) for new and existing systems ... engineering/validation experience (8+ with Master's) * Strong expertise in medical device process ...

INCOG

Process Validation Manager

Fishers, IN · On-site

Supervise, mentor, and develop a team of TSMS process validation engineers (Senior II, Senior I, and Entry Level) while fostering professional growth and technical capabilities * Conduct performance ...

next page

Showing results 1-20

All JobsProcess Validation Engineer Jobs

Process Validation Engineer information

See salary details

$7

$39

$69

How much do process validation engineer jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for process validation engineer 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 are some common challenges faced by Process Validation Engineers during product scale-up?

Process Validation Engineers often encounter challenges when scaling up products from development to full-scale manufacturing. These can include ensuring process consistency, managing variations in equipment or raw materials, and troubleshooting unexpected deviations that may not have surfaced during small-scale trials. Effective communication with cross-functional teams—such as quality assurance, production, and R&D—is essential to quickly address issues and maintain compliance with regulatory requirements. Being proactive and detail-oriented helps navigate these complexities and ensures successful validation outcomes.

What are Process Validation Engineers?

Process Validation Engineers are professionals responsible for ensuring that manufacturing processes consistently produce products that meet predetermined quality standards. They design, execute, and document validation protocols to verify that equipment, systems, and processes operate effectively and efficiently. These engineers play a crucial role in regulated industries such as pharmaceuticals, biotechnology, and medical devices, where compliance with industry standards and regulatory requirements is essential. Their work helps to minimize risks, ensure product safety, and maintain regulatory compliance.

What is the difference between Process Validation Engineer vs Quality Assurance Engineer?

AspectProcess Validation EngineerQuality Assurance Engineer
Primary FocusValidating manufacturing processes to ensure product quality and complianceDeveloping and implementing quality systems and procedures to prevent defects
CertificationsGMP, ISO, Six Sigma often preferredISO, Six Sigma, CQE certifications common
Work EnvironmentManufacturing, pharmaceutical, biotech facilitiesQuality departments across various industries
Key ResponsibilitiesProcess validation, protocol development, troubleshootingAudits, quality audits, process improvements

While both roles aim to ensure product quality, the Process Validation Engineer primarily focuses on validating manufacturing processes, whereas the Quality Assurance Engineer oversees overall quality systems and compliance. Both roles often collaborate but serve distinct functions within the quality management framework.

What are the 4 types of process validation?

For a Process Validation Engineer, the four types of process validation are prospective, concurrent, retrospective, and revalidation. Prospective validation is performed before production, concurrent validation occurs during production, retrospective validation reviews historical data, and revalidation is conducted when changes are made to the process. Understanding these types helps ensure consistent product quality and compliance with regulatory standards.

What does a process validation engineer do?

A process validation engineer is responsible for developing, executing, and documenting validation protocols to ensure manufacturing processes meet quality and regulatory standards. They analyze process data, identify risks, and implement improvements using tools like statistical analysis and validation software. Their work helps ensure products are consistently safe, effective, and compliant with industry regulations.

What engineers make $300,000 a year?

Senior engineers in specialized fields such as petroleum, aerospace, or software engineering can earn $300,000 or more annually, especially with extensive experience, advanced skills, and leadership roles. High compensation often involves working in high-demand industries, holding managerial or executive positions, or possessing rare technical expertise and certifications.

What engineers make $500,000?

Senior engineers in specialized fields such as petroleum, aerospace, or software engineering can earn $500,000 or more annually, especially with experience, advanced skills, and leadership roles. High compensation often includes bonuses, stock options, or profit sharing, and typically requires advanced degrees and extensive industry experience.

What are the key skills and qualifications needed to thrive as a Process Validation Engineer, and why are they important?

To thrive as a Process Validation Engineer, you need a solid background in engineering or life sciences, a thorough understanding of validation protocols, and knowledge of industry regulations such as GMP. Experience with validation software, statistical analysis tools, and familiarity with regulatory documentation systems are typically required. Strong analytical thinking, attention to detail, and effective communication skills help you resolve issues and coordinate cross-functional teams. These skills and qualities are essential to ensure processes are compliant, efficient, and produce high-quality, safe products.
More about Process Validation Engineer jobs
What cities are hiring for Process Validation Engineer jobs? Cities with the most Process Validation Engineer job openings:
What states have the most Process Validation Engineer jobs? States with the most job openings for Process Validation Engineer jobs include:
What job categories do people searching Process Validation Engineer jobs look for? The top searched job categories for Process Validation Engineer jobs are:
What are popular job titles related to Process Validation Engineer jobs? For Process Validation Engineer jobs, the most frequently searched job titles are:
Process Validation Engineer jobs near you
Infographic showing various Process Validation Engineer job openings in the United States as of June 2026, with employment types broken down into 6% Locum Tenens, 6% As Needed, and 88% Full Time. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $82,237 per year, or $39.5 per hour.
Senior Process Validation Engineer

Senior Process Validation Engineer

INCOG BioPharma Services

Fishers, IN

$93K - $121K/yr

Full-time

Posted 4 days ago

Job description

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 Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing practices (cGMP) for clinical and commercial programs. This role will provide advanced technical leadership to ensure robust and reliable production processes are established and maintained across multiple programs.

This position will lead the delivery of technical guidance and assistance throughout the process validation of production processes. The primary objective is to independently execute Process Performance Qualifications and Continued Process Validation activities while mentoring junior staff.

Essential Job Functions:

- Lead TSMS Process Validation activities by providing advanced technical guidance to operations and technical transfer project teams on Process Performance Qualification with minimal supervision

- Independently create complex process qualification documentation such as Process Validation Master Plans, Protocols, Summary Reports, and related validation documents for multiple product lines

- Serve as technical lead in project teams and manage customer communications. Recognized as Subject Matter Expert for multiple manufacturing processes

- Author and review complex GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms across multiple programs

- Monitor and analyze Process Data across multiple manufacturing areas, identify trends and implement corrective actions independently

- Lead technical troubleshooting and investigations of complex process issues to support comprehensive root cause analysis, product impact assessment and effective corrective and preventive actions

- Lead cross-functional teams in assessing and implementing new technology for GMP manufacturing with strategic impact

- Provide advanced technical guidance to team members in technical matters of process validation and mentor Entry Level engineers

- Conduct comprehensive impact assessments of changes to the product, process, equipment, procedures and/or materials across multiple programs

- Demonstrate strong understanding of CMC regulatory requirements specifically with respect to process validation and support regulatory submissions

- Effectively engage and collaborate with both internal and external team members across cross-functional groups and lead client interactions

- Lead identification of continuous improvement opportunities and drive implementation of those improvements with measurable impact

- Stay current with trends and practices in the industry to support best in class processes and share knowledge with team members

- Other responsibilities as required

Special Job Requirements:

- Bachelor's degree in Science or Engineering required

- Master's degree in Science or Engineering preferred

- 3-5 years of GMP experience required

- 2+ years of experience in process validation principles for formulation, aseptic filling and/or combination product (device assembly) processes

- Strong understanding of CMC regulatory requirements and process validation methodologies

- Advanced analytical and problem-solving skills with demonstrated leadership capabilities

- Excellent communication skills and proven ability to lead cross-functional teams and manage client relationships

- Advanced proficiency in Microsoft Office applications, statistical analysis software, and data analysis tools

- Demonstrated ability to work independently in a fast-paced, regulated manufacturing environment

- Experience with regulatory submissions (preferred) and client-facing technical presentations