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System Validation Manager Jobs in Wisconsin (NOW HIRING)

Fujirebio Europe

WI · On-site

Je rondt de volledige validatiecyclus van equipment en utilities af: van system requirements en ... Je rapporteert tijdig over voortgang, issues en risico's aan de Manufacturing Support Manager of ...

Azad Technology Partners

System Administrator

Oregon, WI · On-site

$45 - $52/hr

Working knowledge of IT Service Management software for task management tracking to ensure that work is assigned and updated within the system. * Valid U.S. Driver's License is required. Preferred ...

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System Validation Manager information

What does a system validation manager do?

A System Validation Manager is responsible for overseeing the testing and validation processes of complex systems to ensure they meet the required specifications and quality standards. They coordinate teams, develop validation strategies, and work closely with engineering, quality assurance, and project management teams to identify issues and ensure system reliability. Their role is crucial in industries such as technology, automotive, and healthcare, where system integrity and compliance are essential.

What are the main challenges a system validation manager faces when coordinating cross-functional teams?

A System Validation Manager often collaborates with hardware, software, and quality assurance teams to ensure systems meet all functional and performance requirements. One common challenge is aligning schedules and priorities across departments, which may have competing deadlines or resource constraints. Effective communication and proactive planning are essential to mitigate misunderstandings and ensure thorough validation coverage. Additionally, adapting validation strategies to evolving project scopes or last-minute changes can require quick decision-making and flexibility.

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

To thrive as a System Validation Manager, you need a strong background in systems engineering, validation methodologies, and a related degree such as electrical engineering or computer science. Familiarity with validation tools, test automation frameworks, and quality management systems, as well as certifications like ISTQB, are commonly required. Strong leadership, problem-solving abilities, and effective communication skills help drive cross-functional teams and manage complex validation projects. These skills ensure products meet quality standards, regulatory requirements, and customer expectations, which is critical for successful product launches.

What is the difference between System Validation Manager vs Quality Assurance Manager?

AspectSystem Validation ManagerQuality Assurance Manager
Primary FocusEnsuring systems meet specifications and regulatory requirements through validation processesOverseeing overall quality systems, policies, and continuous improvement
CertificationsOften requires validation or regulatory compliance certificationsQuality management certifications like Six Sigma or ISO
Work EnvironmentTypically in regulated industries like pharmaceuticals, medical devices, or manufacturingAcross various industries including manufacturing, software, and healthcare

The System Validation Manager primarily focuses on validating systems to meet specific standards and regulations, while the Quality Assurance Manager oversees broader quality processes and policies. Both roles require similar certifications and often work in regulated environments, but their scope and responsibilities differ.

What cities in Wisconsin are hiring for System Validation Manager jobs?

Cities in Wisconsin with the most System Validation Manager job openings:

Infographic showing various System Validation Manager job openings in Wisconsin as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Integration (Process Validation) Engineer

Trevor, WI • On-site

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

$70K - $85K/yr

Full-time

Re-posted 21 days ago

Key responsibilities

  • Develop and execute IQ, OQ, and PQ validation protocols and reports.

  • Lead validation activities for manufacturing processes such as flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling.

  • Coordinate cross-functional project activities related to process validation, equipment implementation, and new product integration.

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