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Process Validation Engineer Jobs (NOW HIRING)

Micropulse, Inc.

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Process Validation Engineer

Columbia City, IN · On-site

$20 - $25/hr

Troubleshoot complex validation issues and apply advanced validation engineering and scientific principles to the design and implementation of process modifications Education and/or Experience

FITS LLC

Process Validation Engineer

Dorado, PR · On-site

For Process Validation services in the manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: * Bachelor's in Engineering with five (5) years of experience in Process Validation activities ...

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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.
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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.

Process Validation Engineer

LAPORTE L.C.C.

King Of Prussia, PA • On-site

Full-time

PTO

Posted 10 days ago

Job description

Process Validation Engineer (a minimum of 5 years of experience required)
Location: King of Prussia, PA
Employment Type: Full-time, mostly onsite
About Us
Are you ready to take the next step in your career? LAPORTE, a consulting engineering firm with 25 years of experience and a strong presence in North America and Europe, is seeking an Process Validation Engineer to join our growing team. With 25 offices and over 480 employees worldwide, we specialize in delivering innovative solutions for the pharmaceutical and food & beverage industries.
The Process & Validation Engineer is responsible for supporting the validation of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing sectors. The Process & Validation Engineer will ensure equipment, systems, and validation programs are compliant with a client's global/site standards and industry practices.
The Process & Validation Engineer will live near King of Prussia, PA. They will be motivated to grow and excel with the support and direction from an interdisciplinary team of engineers. Become part of a supportive work environment that emphasizes team culture and empowering engineers with more responsibility, professional growth, and a work-life balance.
At LAPORTE, we offer:
  • Competitive Salary
  • Comprehensive Benefits
  • Compensatory Paid Time Off (PTO)
  • Paid Parental Leave
  • A Flexible Work Environment that values work-life balance
  • Opportunities for Professional Growth

Responsibilities and Duties:
  • Carry out all aspects of a validation project for our clients including: authoring and/or executing Validation Master Plans (VMP), User Requirements Specifications (URS), Risk Assessments (RA), Design Qualification (DQ), Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols/reports in accordance with corporate and departmental procedures.
  • Validation Planning: Develop Validation Master Plans outlining the validation strategy, scope, and timelines for the project.
  • Documentation Management: Oversee the creation, review, and approval of validation protocols, reports, and other documentation required for validation activities.
  • Risk Assessment: Conduct Risk Assessments to identify potential validation issues and develop mitigation strategies to address them.
  • Protocol Execution: Oversee the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems within the QC building.
  • Commissioning Support: Collaborate with the commissioning team to ensure a seamless transition from construction to operation, verifying that systems and equipment are installed correctly and function as intended.
  • Standard Operating Procedure: Provide technical input with respect to Standard Operating Procedures (SOP) development. Revise or develop SOPs in compliance with industry standards and cGMP.
  • Support client Quality Assurance (QA) compliance teams by initiating change controls, documenting deviations, and contributing to the implementation of CAPA (Corrective and Preventive Actions) within validation activities.
  • Perform Periodic Review for various validated systems including computerized systems, laboratory equipment, manufacturing equipment, and infrastructure systems. Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to determine status, gaps, and corrective actions.
  • Maintain up-to-date knowledge of validation requirements, practices, and procedures and coach other members of the team participating in validation activities.
  • Maintain up-to-date knowledge of current GP (Good Practices, e.g. GMP/GLP) regulations, guidelines within North America (Health Canada, US Food & Drug Administration) and EU Eudralex.
  • Maintain effective client relationships and act as a primary point of contact.
  • Ensure that projects are implemented in accordance within the agreed scope, timelines and budget.

Qualifications:
  • Bachelors degree in engineering field or relevant equivalent.
  • Minimum 5 years of prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
  • Excellent knowledge of the Current Good Manufacturing Practices.
  • Excellent communication skills - verbal, written, listening and interpersonal with the ability to transfer knowledge to others.
  • Strong technical knowledge, relationship management, organizational planning, and project management skills.
  • Ability to demonstrate a sense of urgency, flexibility, and accountability.
  • Flexibility to travel to the client site as required.

Preferred Qualifications
  • Prior experience performing GxP risk assessments such as Functional Risk Assessments (FRA) or Failure Mode and Effect Analysis (FMEA).
  • Experience in Aseptic Processing.
  • Familiarity with Computerized Systems Validation and ISPE GAMP5 and 21 CFR Part 11.

Send us your application today. We look forward to meeting you!
The LAPORTE team

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