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Senior Computer System Validation Csv Jobs in Michigan

Lancesoft

Manufacturing Engineer II - Exempt

Dexter, MI · On-site

$45 - $50/hr

Computer System Validation (CSV) * Manufacturing, Packaging, and Laboratory Equipment * Technical experience (Troubleshooting) or any similar experience or background * Quality / Process Control ...

Biovire

Manager of Validation

Brighton, MI · On-site

General Description The Manager of Validation leads the Commissioning, Qualification and Validation (CQV), and Computer System Validation (CSV) area. Ensures that all equipment, facilities, and ...

Biovire

Head of Validation

Brighton, MI · On-site

The Role The Manager of Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical ...

Biovire

Manager of Validation

Brighton, MI

General Description The Manager of Validation leads the Commissioning, Qualification and Validation (CQV), and Computer System Validation (CSV) area. Ensures that all equipment, facilities, and ...

Biovire

Head of Validation

Brighton, MI

The Role The Manager of Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical ...

BoehringerPRD

... computer system and computerized equipment validation within BIAH Operations, including program ... Understands content and compliance requirements for related CSV deliverables and uses this ...

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Senior Computer System Validation Csv information

What are the key skills and qualifications needed to thrive as a Senior Computer System Validation (CSV) professional, and why are they important?

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 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 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:
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Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in Michigan as of May 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.
5910 - CSV Engineer / Validation Engineer

5910 - CSV Engineer / Validation Engineer

Verista, Inc.

Kalamazoo, MI • On-site, Remote

Other

Posted 25 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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