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Validation Analyst Jobs in Wisconsin (NOW HIRING)

Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions * Validate AI/ML-enabled GxP systems ...

Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions * Validate AI/ML-enabled GxP systems ...

Lead CAPA activities for validation findings, including root cause analysis, effectiveness checks, closure documentation, and tracking of open compliance actions * Validate AI/ML-enabled GxP systems ...

WI · On-site

$100 - $125/hr

Supporting qualification and validation of analytical methods** and contributing to the development of computer-controlled systems where applicable, while also providing backup support to fellow ...

WI · On-site

$80 - $100/hr

The Computer System Validation (CSV) Specialist/Engineer will support the validation and lifecycle ... Strong technical writing, documentation, analytical, and problem-solving skills. * Ability to work ...

WI · On-site

$80 - $100/hr

Develop, monitor and validate risk parameters (PD, LGD, EAD): model development, calibration ... tools. * Analyse and explain provisioning movements: assess drivers of loss allowance variations ...

Showing results 21-40

Validation Analyst information

See Wisconsin salary details

$16

$31

$48

How much do validation analyst jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for validation analyst in Wisconsin is $31.83, according to ZipRecruiter salary data. Most workers in this role earn between $25.48 and $36.15 per hour, depending on experience, location, and employer.

What is a validation analyst?

Validation Analysts are professionals responsible for ensuring that systems, processes, or products meet specific regulatory, industry, and company standards. They develop and execute validation protocols, analyze test results, and document compliance with quality and safety requirements. Validation Analysts often work in industries such as pharmaceuticals, biotechnology, and manufacturing, where strict validation of processes is required. Their role is critical in maintaining product integrity and regulatory compliance.

How does a validation analyst typically collaborate with cross-functional teams during a project?

As a Validation Analyst, you will regularly work with cross-functional teams, including Quality Assurance, Regulatory Affairs, Manufacturing, and IT. Your role involves gathering requirements, designing validation protocols, and ensuring compliance with industry standards by facilitating communication between these groups. Effective collaboration is key to resolving issues quickly and ensuring that validation deliverables meet both technical and regulatory expectations. This teamwork not only enhances project success but also provides valuable learning opportunities from experts in related fields.

What are the key skills and qualifications needed to thrive as a validation analyst, and why are they important?

To thrive as a Validation Analyst, you need a strong background in quality assurance, process validation, and regulatory compliance, often supported by a degree in life sciences, engineering, or a related field. Familiarity with validation protocols, data analysis tools, and industry-specific guidelines like FDA or GAMP is typically required. Attention to detail, critical thinking, and strong written and verbal communication skills set outstanding candidates apart. These skills ensure that products and processes consistently meet quality standards and regulatory requirements, minimizing risks and ensuring compliance.

What is the difference between Validation Analyst vs Quality Assurance Analyst?

AspectValidation AnalystQuality Assurance Analyst
Required CredentialsBachelor's in Life Sciences, certifications like CQE or CSQEBachelor's in related fields, certifications like CQE or Six Sigma
Work EnvironmentRegulatory, pharmaceutical, or biotech industriesManufacturing, software, or product development sectors
Employer & Industry UsageUsed in regulated industries for complianceUsed across various industries for process improvement
Common Search & ComparisonOften compared for compliance rolesCompared for quality process roles

The main difference is that Validation Analysts focus on ensuring that processes, equipment, and systems meet regulatory standards, especially in pharma and biotech. Quality Assurance Analysts oversee overall quality processes, including testing and process improvements across industries. Both roles require similar certifications but serve different aspects of quality management.

How much does a validation analyst make?

A validation analyst's average salary in the United States ranges from $60,000 to $85,000 per year, depending on experience, location, and industry. Entry-level roles may start around $50,000, while experienced analysts with certifications can earn over $100,000. The role often requires knowledge of validation protocols, regulatory standards, and data analysis tools.

What are popular job titles related to Validation Analyst jobs in Wisconsin?

For Validation Analyst jobs in Wisconsin, the most frequently searched job titles are:

What job categories do people searching Validation Analyst jobs in Wisconsin look for?

The top searched job categories for Validation Analyst jobs in Wisconsin are:

What cities in Wisconsin are hiring for Validation Analyst jobs?

Cities in Wisconsin with the most Validation Analyst job openings:

Infographic showing various Validation Analyst job openings in Wisconsin as of September 2026, with employment types broken down into 1% Internship, 86% Full Time, 8% Part Time, 1% Temporary, and 4% Contract. Highlights an 81% Physical, 7% Hybrid, and 12% Remote job distribution, with an average salary of $66,202 per year, or $31.8 per hour.

Integration (Process Validation) Engineer

Trevor, WI • On-site

Vonco Products LLC
Plastics Packaging Film and Sheet (including Laminated) Manufacturing • 51 - 200 employees

Other

Re-posted 19 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


Compensation details: 70000-85000 Yearly Salary


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