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Computer System Validation Manager Jobs in Milwaukee, WI

State of Wisconsin

Teacher - Computer Software

Racine, WI · On-site

$31.01/hr

The teacher will monitor and manage student behavior, attend staffing meetings and serve on both ... System as a Teacher of Computer Software, certification Number 103. OR A minimum of 2 years (4,000 ...

DPS Group

CQV Project Manager

Kenosha, WI · On-site

... computer systems. • Develop and execute validation protocols and reports, ensuring compliance with GMP and regulatory standards. • Identify potential risks and develop mitigation strategies to ...

PS SEASONING & SPICES INC

CAD Technician

Hartford, WI · On-site

... Management * Implement engineering change orders (ECOs) by updating drawings and related ... Familiarity with BOM structures and ERP systems is a plus Soft Skills * Strong attention to detail ...

Niemann Foods

Assistant Store Manager

Franklin, WI

Processes information and merchandise through computer system and POS register system. Assists with ... Manages 3-4 associates in the store. * Provide direction, coordination, and evaluation of the store ...

ACE Hardware

Assistant Store Manager

Franklin, WI · On-site

Processes information and merchandise through computer system and POS register system. Assists with ... Manages 3-4 associates in the store. * Provide direction, coordination, and evaluation of the store ...

Niemann Foods

Assistant Store Manager

Franklin, WI · On-site

Processes information and merchandise through computer system and POS register system. Assists with ... Manages 3-4 associates in the store. * Provide direction, coordination, and evaluation of the store ...

Marbach America Inc

CAD Design

Germantown, WI · On-site

$27.50 - $38/hr

Use of proprietary client management system Skills: Proficiency in CAD software, strong analytical skills and attention to detail, familiarity with industry standards, strong organizational skills.

langan

CAD Designer

Milwaukee, WI · On-site

$26.50 - $36.50/hr

... care systems, colleges/universities, and large infrastructure programs throughout the U.S. and ... Manage workload assigned by CAD Production Manager in a timely and efficient manner; * Remain ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Milwaukee, WI

Computer System Validation Manager information

See Milwaukee, WI salary details

$46.8K

$103.9K

$158.1K

How much do computer system validation manager jobs pay per year?

As of Sep 10, 2026, the average yearly pay for computer system validation manager in Milwaukee, WI is $103,860.00, according to ZipRecruiter salary data. Most workers in this role earn between $73,400.00 and $130,100.00 per year, depending on experience, location, and employer.

What does a computer system validation manager do?

A Computer System Validation Manager is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards. They oversee the planning, execution, and documentation of validation activities to ensure systems are reliable, accurate, and secure. Their duties include managing validation projects, writing protocols, coordinating with IT and quality assurance teams, and ensuring adherence to regulations like FDA 21 CFR Part 11. This role is critical for maintaining product quality and regulatory compliance.

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

To thrive as a Computer System Validation Manager, you need expertise in computer system validation regulations (such as GxP, FDA 21 CFR Part 11), strong project management skills, and a background in life sciences or IT. Familiarity with validation lifecycle documentation tools, quality management systems (QMS), and compliance software is often required, along with relevant certifications like PMP or CSV-related credentials. Exceptional attention to detail, analytical thinking, and effective communication are crucial soft skills for coordinating cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to ensure validated systems meet regulatory standards, minimize compliance risks, and support organizational quality objectives.

What are some common challenges a computer system validation manager faces during system implementation projects?

A Computer System Validation Manager often encounters challenges such as aligning validation activities with evolving regulatory requirements, managing tight project timelines, and coordinating between multiple stakeholders like IT, Quality Assurance, and business users. Ensuring thorough documentation and traceability, while adapting to technology updates or scope changes, can also be demanding. Proactive communication and strong project management skills are essential to mitigate risks and ensure successful, compliant system implementations.

What is the difference between Computer System Validation Manager vs Computer System Validation Specialist?

AspectComputer System Validation ManagerComputer System Validation Specialist
CertificationsGAMP, CQE, CSQEGAMP, CQE, CSQE
Work EnvironmentManagement, oversight, strategic planningExecution, testing, documentation
Industry UsagePharmaceutical, biotech, regulated industriesPharmaceutical, biotech, regulated industries
Primary FocusLeading validation projects, team coordinationPerforming validation activities, testing

The main difference between a Computer System Validation Manager and a Computer System Validation Specialist lies in their roles. The manager oversees validation projects, manages teams, and ensures compliance, while the specialist executes validation tasks and documents testing procedures. Both roles require similar certifications and are vital in regulated industries like pharmaceuticals and biotech.

What are popular job titles related to Computer System Validation Manager jobs in Milwaukee, WI?

For Computer System Validation Manager jobs in Milwaukee, WI, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Manager jobs in Milwaukee, WI look for?

The top searched job categories for Computer System Validation Manager jobs in Milwaukee, WI are:

What cities near Milwaukee, WI are hiring for Computer System Validation Manager jobs?

Cities near Milwaukee, WI with the most Computer System Validation Manager job openings:

Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Milwaukee, WI as of August 2026, with employment types broken down into 77% Full Time, 6% Part Time, and 17% Contract. Highlights an 83% In-person, 6% Hybrid, and 11% Remote job distribution, with an average salary of $103,860 per year, or $49.9 per hour.

Integration (Process Validation) Engineer

Salem, WI • On-site

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

Other

Posted 13 days ago

Job description

Integration (Process Validation) Engineer

Vonco Products LLC Trevor, Wisconsin, United States

About this position

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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