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Internship 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 · 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

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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Internship Computer System Validation Csv information

What are the key skills and qualifications needed to thrive as an Internship Computer System Validation (CSV) specialist, and why are they important?

To thrive as an Internship Computer System Validation CSV specialist, you need foundational knowledge in computer science, life sciences, or engineering, along with an understanding of regulatory standards like GxP or FDA 21 CFR Part 11. Familiarity with validation documentation, software testing tools, and quality management systems is typically required. Attention to detail, analytical thinking, and effective communication are crucial soft skills for interpreting requirements and collaborating with cross-functional teams. These skills ensure compliance, data integrity, and the successful validation of computerized systems in regulated environments.

What are some typical responsibilities for an intern in Computer System Validation (CSV), and how do they contribute to the overall validation process?

As a Computer System Validation (CSV) intern, you can expect to assist with tasks such as reviewing and drafting validation documentation, executing test scripts, and collecting evidence to ensure compliance with regulatory requirements. You may also support the maintenance of validation records and participate in team meetings to discuss project progress or findings. These responsibilities are crucial in ensuring that computer systems used in regulated industries, like pharmaceuticals or healthcare, function as intended and meet quality standards. Working closely with senior validation specialists, you'll gain hands-on experience with industry guidelines and learn how cross-functional teams collaborate to achieve compliance.

What is an Internship in Computer System Validation (CSV)?

An Internship in Computer System Validation (CSV) is a temporary position, typically for students or recent graduates, that provides hands-on experience in ensuring that computer systems used in regulated industries (like pharmaceuticals or healthcare) meet required standards and regulations. Interns assist with validating software and hardware, documenting processes, and ensuring compliance with industry guidelines such as FDA 21 CFR Part 11 or EU Annex 11. This role helps interns understand the lifecycle of computer systems in a regulated environment and prepares them for careers in quality assurance, compliance, or IT within highly regulated sectors.

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

AspectInternship Computer System Validation CsvComputer System Validation Specialist
CredentialsTypically pursuing or recent graduate, basic understanding of validationRelevant certifications (e.g., GAMP, ISPE), experience preferred
Work EnvironmentInternship setting, supervised, entry-level tasksFull-time role, independent responsibilities in regulated industries
Industry UsageUsed in pharmaceutical, biotech, and medical device companies for trainingUsed for maintaining compliance, validating systems in regulated environments

In summary, the Internship Computer System Validation Csv is an entry-level position focused on learning and supporting validation tasks, while the Computer System Validation Specialist is a more experienced role responsible for ensuring system compliance and validation in regulated industries.

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 Internship Computer System Validation Csv jobs in Michigan? For Internship Computer System Validation Csv jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Internship Computer System Validation Csv jobs in Michigan look for? The top searched job categories for Internship Computer System Validation Csv jobs in Michigan are:
What cities in Michigan are hiring for Internship Computer System Validation Csv jobs? Cities in Michigan with the most Internship Computer System Validation Csv job openings:
Internship Computer System Validation Csv jobs near you
Infographic showing various Internship Computer System Validation Csv job openings in Michigan as of May 2026, with employment types broken down into 1% As Needed, 80% Full Time, 17% Part Time, 1% Temporary, and 1% Contract. Highlights an 70% Physical, 20% Hybrid, and 10% Remote 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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