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Senior Computer System Validation Csv Jobs in Michigan

Senior Validation Engineer

Rochester, MI · On-site

$83 - $138/hr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems * Experience with sterile products and medical devices

New

Senior Validation Engineer

Rochester, MI · On-site

$82K - $137K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems * Experience with sterile products and medical devices

Senior Automation Engineer

Ravenna, MI · On-site

$94K - $124K/yr

CSV activities are supported indirectly through automation execution and issue resolution. · ... validation, ISA 88, GAMP) and ability to apply them during real time plant execution JD: · Serve ...

New

Senior Automation Engineer

Nunica, MI · On-site

$95K - $124K/yr

CSV activities are supported indirectly through automation execution and issue resolution. · ... validation, ISA 88, GAMP) and ability to apply them during real time plant execution JD: · Serve ...

New

Showing results 41-60

Senior Computer System Validation Csv information

What is a senior computer system validation (CSV) specialist?

A Senior Computer System Validation (CSV) specialist is an experienced professional responsible for ensuring that computer systems used in regulated industries—such as pharmaceuticals, biotechnology, or medical devices—meet compliance standards. This involves planning, executing, and documenting validation activities to demonstrate that systems consistently perform according to predefined specifications and regulatory requirements. Senior CSV specialists often lead validation projects, manage teams, and interact with regulatory auditors, making sure that systems are reliable, secure, and compliant with guidelines like FDA 21 CFR Part 11 and GxP. Their expertise helps organizations avoid compliance issues, data integrity problems, and costly system failures.

What are the key skills and qualifications needed to thrive as a senior computer system validation (CSV) professional?

To excel as a Senior Computer System Validation (CSV) professional, you need deep knowledge of regulatory compliance (such as FDA 21 CFR Part 11), validation lifecycle methodologies, and a background in computer science, engineering, or life sciences. Familiarity with validation management tools, risk assessment software, and quality management systems (QMS) is typically required, along with certifications like GAMP or Six Sigma being highly valued. Outstanding analytical skills, attention to detail, and strong communication abilities set high performers apart in this role. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support quality operations in regulated industries.

What are some common challenges senior computer system validation (CSV) professionals face when working on large-scale projects?

Senior CSV professionals often encounter challenges such as coordinating validation activities across multiple departments, managing evolving regulatory requirements, and ensuring thorough documentation throughout the project lifecycle. They also need to balance project timelines with the need for comprehensive testing and risk assessments. Effective communication and collaboration with IT, QA, and business stakeholders are essential to address issues proactively and ensure compliance in complex, regulated environments.

What is the difference between Senior Computer System Validation Csv vs Computer System Validation Specialist?

AspectSenior Computer System Validation CsvComputer System Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRegulated industries like pharma, biotech, medical devicesRegulated industries like pharma, biotech, medical devices
ResponsibilitiesLeading validation projects, ensuring compliance, mentoringExecuting validation activities, documentation, testing

While both roles require similar certifications and work in regulated environments, the Senior Computer System Validation Csv typically involves leading projects and overseeing compliance efforts, whereas the Computer System Validation Specialist focuses on executing validation tasks and documentation. The senior role often requires more experience and leadership responsibilities.

What are the most commonly searched types of Computer System Validation Csv jobs in Michigan?

The most popular types of Computer System Validation Csv jobs in Michigan are:

What are popular job titles related to Senior Computer System Validation Csv jobs in Michigan?

For Senior Computer System Validation Csv jobs in Michigan, the most frequently searched job titles are:

What cities in Michigan are hiring for Senior Computer System Validation Csv jobs?

Cities in Michigan with the most Senior Computer System Validation Csv job openings:

Infographic showing various Senior Computer System Validation Csv job openings in Michigan as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, 2% Temporary, 3% Contract, and 1% Nights. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

System Integration & Testing Engineer (MPL/Senior) - On-site

IAV Automotive Engineering Inc

Novi, MI • On-site

$156K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 3 days ago


Job description

IAV is offering exciting opportunities to join dynamic teams with exposure to top tier projects!

IAV Group is an engineering and technical consultancy servicing the global automotive industry with approximately 7,000 employees worldwide and more than 40 years of experience. As a recognized leader in the specification, design, development, validation and production launch of advanced vehicle and powertrain systems, IAV Automotive Engineering deploys a leading team of technical experts, engineering tools and program processes from its North American Headquarters in Novi, Michigan.

IAV is currently seeking a highly motivated System Integration & Testing Engineer (MLP / Senior) is responsible for integrating hardware and software components into a complete system and validating that the system meets all functional and performance requirements. This role plays a critical part in the verification and validation (V&V) process by designing and executing test strategies, identifying issues, and ensuring that the product is robust, safe, and reliable prior to deployment.

The ideal candidate will play a key role in delivering innovative, high-quality electrical solutions from concept through production while collaborating across engineering, manufacturing, and supplier teams in a fast-paced, customer-focused environment.

Why Join Us:

At IAV, you'll be part of a global leader in automotive engineering. We offer a dynamic work environment, opportunities for professional growth, and a culture that values innovation, collaboration, and diversity. Join us in driving the future of mobility.

Essential Responsibilities & Activities:

  • Lead test planning, integration management, change management, and software release management for vehicle development programs.
  • Integrate embedded software, ECUs, sensors, actuators, and communication networks such as CAN, LIN, and Ethernet.
  • Manage configuration, flashing, and version control of software into Electronic Control Units (ECUs).
  • Develop test scope, schedules, and deploy bench integration environments with defined requirements for simulator I/O, instrumentation, and automation solutions.
  • Design and manage test environments and instrumentation strategies to enable automated and functional integration testing of distributed vehicle features.
  • Collaborate with Software, Hardware, suppliers, and cross-functional teams to ensure seamless integration, issue resolution, and test execution.
  • Perform test bench integration across ECUs, control units, sensors, and actuators into Hardware-in-the-Loop (HIL) systems.
  • Validate and troubleshoot simulators, vehicle systems, and automation solutions within test environments to detect and resolve hardware/software integration issues early.
  • Execute both manual and automated testing, analyze results, and generate detailed test reports aligned with sprint or program schedules.
  • Lead continuous improvement initiatives to expand automation, enhance test reliability, and optimize execution efficiency.
  • Support troubleshooting and debugging of EE (Electrical/Electronic) system components across HW/SW domains.

Requirements

  • Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, Mechanical Engineering, or a related technical field.
  • Experience with test tools and platforms such as dSPACE, National Instruments (NI), CANoe, CANalyzer, Vehicle Spy.
  • Strong experience with automated testing frameworks and continuous integration pipelines.
  • Knowledge of automotive development processes (e.g., ASPICE, V-model, Agile).
  • Experience supporting full vehicle development lifecycle from concept through validation and launch.
  • Familiarity with ECU diagnostics, network simulation, and communication protocols.
  • Experience in improving test processes, automation coverage, and system validation strategies.
  • Strong analytical and problem-solving skills with attention to detail.
  • Ability to build strong relationships and collaborate effectively across cross-functional and global teams.
  • Excellent organizational skills with strong attention to detail.
  • Strong proficiency with verbal and written communication skills, analytical problem solving, and creativity.
  • Willingness to travel, as needed

Benefits

  • 401K with company matching
  • PTO (Paid Time Off) starts at 20days/year with 1 day accumulation per year
  • Health/Dental/Vision insurance starts on date of hire
  • Health saving account
  • Flexible spending account
  • Life insurance
  • Short-Term & Long-Term Disability (covered 100% premium)
  • Tuition reimbursement
  • Training and Development
  • Paid Holidays
  • Employee assistance program
  • Employee Discount
  • Referral program