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Process Validation Engineer Jobs (NOW HIRING)

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 ...

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)

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 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 ...

Intellectt INC

Validation Engineer

San Diego, CA · On-site

Validation Engineer Location: San Diego, CA Duration: Longterm Job Summary: A Validation Engineer ... Execute validation protocols for equipment qualification, process validation, cleaning validation ...

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Process Validation Engineer information

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How much do process validation engineer jobs pay per hour?

As of Jul 22, 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 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 July 2026, with employment types broken down into 1% Locum Tenens, 95% Full Time, 1% Part Time, and 3% Contract. 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.
Integration (Process Validation) Engineer

Integration (Process Validation) Engineer

Vonco Products LLC

Trevor, WI • On-site

Full-time

Re-posted 21 days ago

Job description

Job Type
Full-time
Description
Integration (Process Validation) Engineer
Medical Device Contract Manufacturer - Flexible Films & Packaging
Position Summary
The Integration (Process Validation) Engineer is responsible for leading and supporting process validation and manufacturing integration activities for medical device packaging, flexible film converting, and related manufacturing processes. This role ensures manufacturing processes are developed, validated, transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements, and internal quality standards.
The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.
Reporting Structure
• Reports To: VP of Quality and Integration Engineering
• Department: Integration Engineering
Essential Duties and Responsibilities
• Develop and execute IQ, OQ, and PQ validation protocols and reports.
• Lead validation activities for flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling operations.
• Perform process capability studies and statistical analysis to support validation activities.
• Establish process windows, critical process parameters, and acceptance criteria.
• Support new product introductions (NPI) from concept through commercial production.
• Identify and implement process improvements focused on quality, efficiency, scrap reduction, and throughput.
• Lead root cause investigations and corrective actions related to process performance.
• Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements.
• Support internal, customer, and regulatory audits.
Project Management & Customer Communication
• Lead cross-functional project activities related to process validation, equipment implementation, and new product integration.
• Develop and manage project timelines, deliverables, and validation schedules to support customer and internal milestones.
• Coordinate activities between Engineering, Quality, Operations, Supply Chain, and customer teams to ensure successful project execution.
• Serve as a primary technical point of contact for customers during new product introductions, validation activities, process transfers, and ongoing manufacturing support.
• Communicate project status, technical risks, validation progress, and issue resolution plans to internal leadership and customers.
• Facilitate customer meetings, technical reviews, and validation planning discussions.
• Support quotation reviews and provide technical input related to manufacturability, process capability, and validation requirements.
• Collaborate with customers to understand product requirements, critical-to-quality characteristics, and regulatory expectations.
• Support customer visits, audits, factory acceptance activities, and production trials as needed.
Requirements
Required Qualifications
• Bachelor's degree in Engineering or related technical field required.
• 3+ years of engineering experience in a regulated manufacturing environment.
• Experience with process validation in regulated manufacturing.
• Working knowledge of IQ/OQ/PQ methodologies, statistical analysis, root cause analysis tools, and risk management methodologies.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
• Strong technical writing and documentation skills.
Preferred Qualifications
• Experience in flexible films, medical packaging, or converting operations.
• Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
• Experience supporting customer audits and regulatory inspections.
• Experience with EQMS systems.
Key Competencies
• Strong analytical and problem-solving skills
• Project management and organizational skills
• Attention to detail and documentation accuracy
• Effective communication and collaboration skills
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• Customer-focused mindset

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