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Computer System Validation Csv Remote Jobs in Michigan

Maximus

System Test Engineer

Ann Arbor, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Lansing, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Kalamazoo, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Detroit, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Rochester Hills, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Warren, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Sterling Heights, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Allendale, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Grand Rapids, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Mount Pleasant, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Flint, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

Maximus

System Test Engineer

Berrien Springs, MI · Remote

This position is remote and requires an active Secret clearance or higher. Maximus TCS (Technology ... and system validation - Develop test documentation and procedures supporting verification ...

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Computer System Validation Csv Remote information

What are the key skills and qualifications needed to thrive as a Computer System Validation (CSV) specialist in a remote role, and why are they important?

To excel as a Computer System Validation (CSV) specialist, you need a solid background in computer science or life sciences, experience with GxP regulations, and knowledge of validation documentation standards. Familiarity with validation management tools, electronic quality management systems (eQMS), and understanding regulatory frameworks like FDA 21 CFR Part 11 or EU Annex 11 is crucial. Strong attention to detail, problem-solving skills, and effective remote communication set top performers apart. These competencies ensure validated systems meet compliance requirements, maintain data integrity, and support regulatory audits in remote environments.

What are some common challenges faced by Computer System Validation (CSV) professionals working remotely, and how can they be addressed?

Remote CSV professionals often encounter challenges such as coordinating validation activities across different teams, ensuring secure access to validation environments, and maintaining clear documentation. Effective communication is key—using project management tools and regular virtual meetings helps keep everyone aligned. It's also important to implement robust cybersecurity measures and standardized documentation practices to ensure compliance. Proactively addressing these challenges fosters a smooth validation process and supports regulatory requirements.

What is a Computer System Validation (CSV) specialist and what do they do remotely?

A Computer System Validation (CSV) specialist is responsible for ensuring that computer systems used in regulated industries, such as pharmaceuticals or biotechnology, meet all required compliance standards and function as intended. When working remotely, CSV specialists perform tasks like developing validation protocols, reviewing documentation, executing test scripts, and liaising with teams via digital tools to ensure systems adhere to regulatory guidelines. Their work helps guarantee data integrity, product quality, and regulatory compliance in industries where strict standards are critical.

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

AspectComputer System Validation Csv RemoteComputer Validation Specialist
CertificationsGxP, 21 CFR Part 11, CSV certificationsGxP, 21 CFR Part 11, CSV certifications
Work EnvironmentRemote, regulated industries like pharma and biotechOn-site or hybrid in regulated industries
Industry UsagePharmaceutical, biotech, medical devicesPharmaceutical, biotech, medical devices
Job FocusValidating computer systems and software complianceValidating computer systems and software compliance

Both roles require similar certifications and work in regulated industries like pharma and biotech. The main difference is that Computer System Validation Csv Remote typically involves remote work, focusing on validating computer systems remotely, while Computer Validation Specialist may work on-site or in hybrid settings. Both roles aim to ensure compliance with industry standards and regulations.

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 Computer System Validation Csv Remote jobs in Michigan? For Computer System Validation Csv Remote jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Csv Remote jobs in Michigan look for? The top searched job categories for Computer System Validation Csv Remote jobs in Michigan are:
What cities in Michigan are hiring for Computer System Validation Csv Remote jobs? Cities in Michigan with the most Computer System Validation Csv Remote job openings:
Computer System Validation Csv Remote jobs near you
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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