ZipRecruiter

Log In

1

Senior 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

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 ...

Haworth

Senior Cloud Identity Systems Engineer

Holland, MI · On-site

$97K - $133K/yr

We are currently looking for a Senior Computer Systems Engineer to join our team in Holland, MI. Job Overview The Senior Computer Systems Engineer is responsible for designing, operating, and ...

next page

Showing results 1-20

All JobsComputer System Validation Csv JobsSenior Computer System Validation Csv JobsSenior Computer System Validation Csv Jobs in Michigan

Senior Computer System Validation Csv information

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 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 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 Senior Computer System Validation Csv jobs in Michigan? For Senior Computer System Validation Csv jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Senior Computer System Validation Csv jobs in Michigan look for? The top searched job categories for Senior Computer System Validation Csv jobs in Michigan are:
What cities in Michigan are hiring for Senior Computer System Validation Csv jobs? Cities in Michigan with the most Senior Computer System Validation Csv job openings:
Senior Computer System Validation Csv jobs near you
Infographic showing various Senior Computer System Validation Csv job openings in Michigan as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

Head of Validation

Biovire

Brighton, MI • On-site

Full-time

Medical, Dental, Vision, Life, PTO

Re-posted 25 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.