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Senior Computer System Validation Csv Jobs in Michigan

Socket.dev

Senior Validation Engineer

Rochester, MI · On-site

$82.70 - $137.90/hr

  • Medical

  • Retirement

  • PTO

Overview The Rochester Senior Validation Engineer leads planning, scheduling, executing and guiding ... and/or computer systems. * Experience with sterile products and medical devices. * Strong ...

New

Corium Innovations

Validation Engineer

Grand Rapids, MI

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

... Sr. Validation Engineer who will be responsible for the maintenance and execution of the site validation programs including equipment, facilities, utilities, lab instrumentation and computer systems ...

Stellantis

AI Validation Engineer

Auburn Hills, MI · On-site

... of these systems is critical for successful deployment. We are seeking a Senior AI Validation ... Bachelor's degree in computer science, Machine Learning, Data Science, Electrical Engineering, or a ...

Magna

Senior CAD Engineer

Troy, MI · On-site

$97K - $134K/yr

... system. This position has a high level of responsibility and visibility and will interface with ... Collaborate with Vehicle Development group on DFMEA / DVP / Validation * Collaborate with all cross ...

Magna

Senior CAD Engineer

Troy, MI · On-site

$99K - $136K/yr

... system. This position has a high level of responsibility and visibility and will interface with ... Collaborate with Vehicle Development group on DFMEA / DVP / Validation * Collaborate with all cross ...

Magna

Senior CAD Engineer

Troy, MI · On-site

$99K - $136K/yr

... system. This position has a high level of responsibility and visibility and will interface with ... Collaborate with Vehicle Development group on DFMEA / DVP / Validation * Collaborate with all cross ...

Stellantis

AI Validation Engineer

Auburn Hills, MI · On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... of these systems is critical for successful deployment. We are seeking a Senior AI Validation ... Bachelor's degree in computer science, Machine Learning, Data Science, Electrical Engineering, or a ...

Polaris Inc.

Sr. Cybersecurity Validation Engineer

Novi, MI · On-site

$120 - $160/hr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Engineer, Systems Electrical Sr - Cybersecurity Location: Novi, Michigan Responsibilities * Work ... Qualifications * Bachelor's degree in Electrical Engineering, Computer Science, Software ...

Polaris, Inc.

Sr. Cybersecurity Validation Engineer

Novi, MI · Hybrid

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Engineer, Systems Electrical Sr - Cybersecurity Position Description: Polaris Industries, Inc ... Requires a Bachelor's degree in Electrical Engineering, Computer Science, Software Engineering ...

Polaris, Inc.

Sr. Cybersecurity Validation Engineer

Novi, MI · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Engineer, Systems Electrical Sr - Cybersecurity Position Description: Polaris Industries, Inc ... Requires a Bachelor's degree in Electrical Engineering, Computer Science, Software Engineering ...

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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 job categories do people searching Senior Computer System Validation Csv jobs in Michigan look for?

The top searched job categories for Senior Computer System Validation Csv jobs in Michigan 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:

Senior Computer System Validation Csv jobs near you
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.

Senior Validation Engineer

Socket.dev

Rochester, MI • On-site

$82.70 - $137.90/hr

Other

Medical, Retirement, PTO

Posted yesterday

New

Job description

Overview

The Rochester Senior Validation Engineer leads planning, scheduling, executing and guiding validation projects related to manufacturing processes, equipment, critical utilities, product, cleaning and sterilization. This role develops and authorizes project plans, protocols, test scripts and reports across the full lifecycle from initiation to ongoing monitoring. Collaboration with area owners and suppliers ensures validation/qualification requirements align with company policies, procedures and regulatory guidelines. The position may include troubleshooting, gap and risk assessments, regulatory inspection support and required training.

Responsibilities
  • Support validation/qualification of manufacturing equipment, facilities and critical utility systems.
  • Validate product, cleaning, shipping, aseptic processing (media fill) and sterilization (steam) cycles.
  • Validate laboratory equipment.
  • Develop and execute validation life-cycle documents (FRS, URS, FATs, SATs, DQ, IQ, OQ, PQ) and other relevant materials.
  • Develop/author validation master plans, SOPs, programs and policies; conduct system impact assessments, risk assessments and validation/qualification protocols (facility, equipment, process, product, change/modifications) and periodic requalification.
  • Coordinate cross-functionally with multiple departments to schedule and complete activities.
  • Support corrective actions, investigations and deviations as they relate to validation.
  • Provide technical training on processes and technologies as required by projects.
  • Assist in audit preparation and defend areas of Validation responsibility.
  • Carry out process capability analysis on commercial processes periodically and identify improvement opportunities where capability is unacceptable.
  • Prepare and review sections of the Annual Product Quality Reports (APQR).
  • Review site change controls to ensure validated state is not impacted by proposed changes.
  • Lead projects to reduce process risk and optimize plant and process productivity.
  • Where applicable, complete qualification in aseptic gowning and cleanroom techniques (Grade A through D).
Basic Requirements
  • Bachelor’s degree with at least 2 years of experience; or a Master’s degree with 0+ years; or an Associate’s degree with 6 years; or a high school diploma (or equivalent) with 8 years of relevant experience.
Preferred Requirements
  • Strong technical knowledge in validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.
  • Experience with sterile products and medical devices.
  • Strong analytical, problem-solving, organizational and time management skills.
  • Ability to mentor and guide colleagues.
  • Experience in regulatory audits and compliance.
  • Experience using AI tools (e.g., ChatGPT, Microsoft Copilot) to support problem solving; demonstrated curiosity in responsible AI practices including risk management and ethical use.
Physical/Environmental Requirements

This is a penicillin manufacturing facility; candidates must not be allergic to penicillin and must be able to aseptically gown. Ability to lift 25–30 lbs.

Work Schedule and Travel

Non-standard work schedule may be required to support product release, including weekends, second shift, night shift, or on-call decisions. Minimal travel for training/seminars. Relocation assistance may be available.

Location and Compensation

Work Location: On Premise. Salary range: $82,700.00 to $137,900.00. Eligible for Pfizer Global Performance Plan with a target bonus of 10% of base salary. Benefits include 401(k) with company matching, retirement contributions, paid time off, caregiver/parental and medical leave, and comprehensive health benefits. Hiring is subject to location and eligibility requirements.

EEO, Compliance and Accessibility

Pfizer is an equal opportunity employer. We comply with applicable nondiscrimination laws and work authorization requirements. This posting complies with accessibility standards and provides accommodation on request via disabilityrecruitment@pfizer.com. Information on AI usage guidelines for recruitment is available on Pfizer Careers.

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