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Computer System Validation Manager Jobs in Decatur, MI

R3 Tek

System Integrator

Benton Harbor, MI

Candidate Profile ๏‚ท System Integration, Product validation and verification, Project management, root cause analysis. ๏‚ท Knowledge in given category Exceptional systems thinker, Excellent ...

Note Tech Industries LLC

Computer Technician

Mishawaka, IN

$17.25 - $22.75/hr

Computer Technician Template We are looking for a motivated and highly technical Computer Technician to manage, monitor, and repair our computer systems, and also ensure that systems are configured ...

Beacon Health System

Systems Analyst IV

Granger, IN

... computer system security. Ability to handle the most complex issues. Provides training and acts as a mentor to other Systems Analysts. Perform project management for small to large projects. Utilizes ...

Beacon Health System

Systems Analyst IV

Granger, IN ยท On-site

... computer system security. Ability to handle the most complex issues. Provides training and acts as a mentor to other Systems Analysts. Perform project management for small to large projects. Utilizes ...

Beacon Health System

Systems Analyst I

Granger, IN ยท On-site

Reports to the Application Manager. Responsibilities are the coordination of assigned computer ... Assists in performing system tests and analyzing test results. * Analyzes situations or data by ...

Beacon Health System

Systems Analyst I

Granger, IN

Reports to the Application Manager. Responsibilities are the coordination of assigned computer ... Assists in performing system tests and analyzing test results. * Analyzes situations or data by ...

Whirlpool

System Integration Senior Engineer

Saint Joseph, MI ยท On-site

$98.70K - $135.50K/yr

Responsible for driving full system validation through use of predictive validation methodologies in concept, design and product validation stages. * Change management to monitor the changes, risks ...

Beacon Health System

Coder I

Granger, IN ยท On-site

Reports to the Manager, Coding & Records. Reviews, codes, and analyzes medical records in order to abstract relevant data from patient medical records into the on-line computer system. Assigns DRGs ...

Beacon Health System

Coder I

Granger, IN

Reports to the Manager, Coding & Records. Reviews, codes, and analyzes medical records in order to abstract relevant data from patient medical records into the on-line computer system. Assigns DRGs ...

Beacon Health System

Coder I

Granger, IN

Reports to the Manager, Coding & Records. Reviews, codes, and analyzes medical records in order to abstract relevant data from patient medical records into the on-line computer system. Assigns DRGs ...

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All JobsComputer System Validation JobsComputer System Validation Manager JobsComputer System Validation Manager Jobs in Decatur, MI

Computer System Validation Manager information

See Decatur, MI salary details

$43.8K

$97.3K

$148.1K

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

As of May 30, 2026, the average yearly pay for computer system validation manager in Decatur, MI is $97,280.00, according to ZipRecruiter salary data. Most workers in this role earn between $68,800.00 and $121,800.00 per year, depending on experience, location, and employer.

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 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 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 the most commonly searched types of Computer System Validation jobs in Decatur, MI? The most popular types of Computer System Validation jobs in Decatur, MI are:
What job categories do people searching Computer System Validation Manager jobs in Decatur, MI look for? The top searched job categories for Computer System Validation Manager jobs in Decatur, MI are:
Computer System Validation Manager jobs near you
Infographic showing various Computer System Validation Manager job openings in Decatur, MI as of May 2026, with employment types broken down into 43% Full Time, 50% Part Time, and 7% Contract. Highlights an 85% Physical, and 15% Remote job distribution, with an average salary of $97,280 per year, or $46.8 per hour.
5910 - CSV Engineer / Validation Engineer

5910 - CSV Engineer / Validation Engineer

Verista, Inc.

Kalamazoo, MI โ€ข On-site, Remote

Other

Posted 26 days ago

Job description

Validation Engineer Responsibilities:

  • Execute Computer System Validation activities for Electronic Batch Record (EBR) systems supporting aseptic fill operations in compliance with cGMP, 21 CFR Part 11, and EU Annex 11
  • Support development and review of validation deliverables including URS, FDS, risk assessments, and validation plans in alignment with GAMP 5 principles
  • Collaborate with Operations, Quality, Engineering, IT, and Automation teams to define system requirements, intended use, and validation scope
  • Participate in execution and documentation of validation testing (IQ, OQ, PQ), including deviation tracking and resolution support
  • Support validation of interfaces between PLC/SCADA systems and MES/EBR platforms to ensure data integrity and accurate batch execution
  • Maintain organized, inspection-ready validation documentation and support change control and periodic review activities for validated EBR systems

Requirements:

  • Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical field
  • 3+ years of hands-on Computer System Validation (CSV) experience in a regulated pharmaceutical or biotechnology environment, supporting MES and/or Electronic Batch Record (EBR) systems
  • Working knowledge of cGMP regulations, including 21 CFR Part 11 and EU Annex 11, and application of GAMP 5 principles across the system lifecycle
  • Experience supporting validation documentation and testing activities (URS, FDS, risk assessments, IQ/OQ/PQ) and managing deviations and change controls
  • Ability to collaborate effectively with cross-functional teams (Operations, Quality, Engineering, IT, Automation) and support system interfaces with PLC/SCADA-controlled equipment
  • Ability to travel/be on-site up to 25% of the time in Kalamazoo, MI. This role can be 75% remote.

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