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Lead Validation Engineer Jobs (NOW HIRING)

Syner-G

Validation Engineer

Waltham, MA · On-site

The Validation Engineer will act as a technical subject matter expert across facility systems, lead validation efforts, support lifecycle management, mentor junior staff, and collaborate cross ...

Syner-G

Validation Engineer

Waltham, MA

The Validation Engineer will act as a technical subject matter expert across facility systems, lead validation efforts, support lifecycle management, mentor junior staff, and collaborate cross ...

Pinnaql

Validation Engineer

Atlanta, GA · On-site

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions ... Lead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.

Pinnaql

Validation Engineer

Atlanta, GA

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions ... Lead full validation lifecycle activities: FAT, SAT, CSV, equipment integration, and startup.

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Lead Validation Engineer information

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$42.5K

$123.8K

$180.5K

How much do lead validation engineer jobs pay per year?

As of May 29, 2026, the average yearly pay for lead validation engineer in the United States is $123,784.00, according to ZipRecruiter salary data. Most workers in this role earn between $102,500.00 and $135,000.00 per year, depending on experience, location, and employer.

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

To thrive as a Lead Validation Engineer, you need expertise in test planning, validation methodologies, and a degree in engineering or a related technical field. Familiarity with validation tools (like LabVIEW or MATLAB), regulatory standards (such as FDA or ISO), and quality management systems is typically required. Strong leadership, problem-solving, and communication skills set top candidates apart in overseeing teams and complex projects. These competencies are vital to ensure products meet safety, quality, and regulatory standards while guiding teams to successful project outcomes.

What are some common challenges faced by Lead Validation Engineers when coordinating cross-functional validation activities?

Lead Validation Engineers often encounter challenges in aligning timelines and expectations among diverse teams such as design, manufacturing, and quality assurance. Balancing compliance requirements with project deadlines can be demanding, as validation activities frequently depend on input and deliverables from multiple stakeholders. Strong communication and project management skills are essential to ensure smooth collaboration and to proactively address issues like resource constraints or shifting priorities. Overcoming these challenges not only strengthens the validation process but also enhances product quality and team cohesion.

What are Lead Validation Engineers?

Lead Validation Engineers are professionals responsible for overseeing the validation processes in manufacturing or product development environments. They ensure that systems, equipment, or products meet regulatory standards, quality requirements, and function as intended. Their role typically involves developing validation protocols, managing a team, coordinating testing activities, and documenting results. Lead Validation Engineers often work in industries such as pharmaceuticals, biotechnology, automotive, or electronics. They play a critical role in maintaining product safety, compliance, and reliability.

What is the difference between Lead Validation Engineer vs Validation Engineer?

AspectLead Validation EngineerValidation Engineer
CredentialsTypically requires a bachelor's degree in engineering or related field; certifications like ISTQB or Six Sigma are commonSame as Lead Validation Engineer, often with similar certifications
Work EnvironmentLeads validation projects, manages teams, and collaborates with cross-functional departmentsPerforms validation tasks, executes test plans, and documents results under supervision
Industry UsageUsed in manufacturing, pharmaceuticals, and software industries for quality assuranceCommonly used in similar industries for ensuring product and process quality

The main difference is that the Lead Validation Engineer oversees validation projects and manages teams, while the Validation Engineer focuses on executing validation tasks. Both roles require similar credentials and are integral to quality assurance processes across industries.

More about Lead Validation Engineer jobs
Who are the top companies hiring for Lead Validation Engineer jobs? The top employers for Lead Validation Engineer jobs are:
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Lead Validation Engineer jobs near you
Infographic showing various Lead Validation Engineer job openings in the United States as of May 2026, with employment types broken down into 30% Full Time, 55% Part Time, 3% Temporary, and 12% Contract. Highlights an 68% Physical, 26% Hybrid, and 6% Remote job distribution, with an average salary of $123,784 per year, or $59.5 per hour.
Integration (Process Validation) Engineer

Integration (Process Validation) Engineer

Vonco Products LLC

Trevor, WI • On-site

Full-time

Posted 6 days ago

Job description

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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