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Internship Computer System Validation Csv Jobs in Michigan

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

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

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 ...

BoehringerPRD

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

Stellantis

Validation Project Chief

Auburn Hills, MI · On-site

Stellantis is seeking an EE Validation Project Chief (VPC) to lead and coordinate electrical system ... Bachelor of Science in Electrical Engineering, Automotive Engineering, Computer Engineering, or ...

Stellantis

Validation Project Chief

Auburn Hills, MI · On-site

Stellantis is seeking an EE Validation Project Chief (VPC) to lead and coordinate electrical system ... Bachelor of Science in Electrical Engineering, Automotive Engineering, Computer Engineering, or ...

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Internship Computer System Validation Csv information

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 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 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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Internship Computer System Validation Csv jobs near you

Head of Validation

Biovire

Brighton, MI • On-site

Full-time

Medical, Dental, Vision, Life, PTO

Posted 11 days ago

Job description

Head of Validation Brighton, Michigan

Biovire is advancing toward commercialization with a focus on operational excellence, compliance, and scalable GMP manufacturing systems. We are seeking a Manager of Validation to lead validation programs supporting equipment, facilities, utilities, and computerized systems within our regulated pharmaceutical manufacturing environment.

This is a highly visible leadership role responsible for ensuring validation programs support operational readiness, inspection readiness, and long-term manufacturing reliability as the organization continues to scale.

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 oversight for validation strategy, execution, compliance, and lifecycle management of manufacturing systems and infrastructure.

This position partners closely with Quality, Manufacturing, Engineering, Maintenance, and cross-functional operational teams to ensure all systems remain compliant, qualified, and inspection-ready.

Key Responsibilities

  • Lead site validation programs supporting equipment, facilities, utilities, and computerized systems
  • Oversee commissioning, qualification, and validation activities in accordance with cGMP requirements
  • Manage and maintain Validation Master Plans and validation lifecycle documentation
  • Lead scheduling, planning, review, and execution of validation activities
  • Support transition of equipment and systems from Engineering to operational use
  • Partner cross-functionally with Quality, Manufacturing, Engineering, and Maintenance teams
  • Provide technical guidance for risk assessments, change controls, deviations, and investigations
  • Ensure timely completion of validation protocols, reports, traceability matrices, IQ/OQ documentation, and related deliverables
  • Support audit and inspection readiness activities
  • Lead and develop validation personnel while reinforcing a strong quality and compliance culture

What You Bring

  • Bachelor's degree in Engineering, Science, Computer Systems, or related technical field
  • 5+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments
  • Prior leadership experience within Validation, Engineering, CQV, or Quality functions
  • Strong understanding of cGMP, validation lifecycle management, and 21 CFR Part 11 requirements
  • Hands-on experience leading validation projects and technical documentation activities
  • Experience supporting manufacturing equipment, utilities, HVAC, automation systems, and/or computerized systems
  • Strong organizational, communication, and cross-functional collaboration skills

Why Join Biovire

  • Opportunity to shape and strengthen validation systems during organizational growth
  • High visibility and cross-functional leadership exposure
  • Collaborative and mission-driven GMP manufacturing environment
  • Direct impact supporting operational readiness and future commercialization
  • Company-paid medical, dental, vision, and life insurance
  • Paid Time Off supporting work-life balance

Come join us on our mission of manufacturing safe, high-quality products that improve and save lives.

Apply