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Csv Validation Engineer Jobs in Michigan (NOW HIRING)

Biovire

Head of Validation

Brighton, MI · On-site

We are seeking a Manager, Validation, reporting to the VP, Engineering, to lead validation programs ... CSV) activities across the Brighton site. This role provides technical oversight for validation ...

Biovire

Head of Validation

Brighton, MI · On-site

We are seeking a Manager, Validation, reporting to the VP, Engineering, to lead validation programs ... CSV) activities across the Brighton site. This role provides technical oversight for validation ...

Biovire

Head of Validation

Brighton, MI · On-site

We are seeking a Manager, Validation, reporting to the VP, Engineering, to lead validation programs ... CSV) activities across the Brighton site. This role provides technical oversight for validation ...

BoehringerPRD

... CSV deliverables and uses this knowledge to improve consistency across the system validation ... Bachelor of Science in Engineering, Information Technology, Chemistry or related Science/Technology ...

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Csv Validation Engineer information

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$20

$44

$74

How much do csv validation engineer jobs pay per hour?

As of Jul 31, 2026, the average hourly pay for csv validation engineer in Michigan is $44.68, according to ZipRecruiter salary data. Most workers in this role earn between $33.41 and $53.94 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a CSV Validation Engineer, and why are they important?

To thrive as a CSV (Computer System Validation) Validation Engineer, you need expertise in validation methodologies, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, documentation systems, and quality management software is typically required, along with knowledge of industry standards like GAMP 5. Strong attention to detail, analytical thinking, and effective communication skills set outstanding candidates apart. These competencies ensure validated systems meet regulatory requirements, maintain data integrity, and support safe, compliant operations in regulated environments.

What are Csv Validation Engineers?

CSV Validation Engineers are professionals responsible for ensuring that computerized systems used in regulated industries, such as pharmaceuticals or biotechnology, comply with industry standards and regulations. CSV stands for Computer System Validation, which involves testing and documenting that systems function as intended and meet regulatory requirements for data integrity and security. These engineers typically create validation protocols, perform risk assessments, and support audits. Their work is crucial to ensure that electronic records and processes are reliable, traceable, and meet legal and industry guidelines.

What are some common challenges faced by a CSV Validation Engineer when working with cross-functional teams?

As a CSV Validation Engineer, one common challenge is ensuring clear communication and understanding between IT, QA, and business process teams regarding regulatory requirements and validation protocols. Misalignment on validation deliverables or timelines can occur, especially when teams have differing priorities or levels of familiarity with compliance frameworks. Proactively facilitating discussions, clarifying documentation, and providing training on Computer System Validation standards can help bridge gaps and keep projects on track.

What is the difference between Csv Validation Engineer vs Data Quality Analyst?

AspectCsv Validation EngineerData Quality Analyst
Required CredentialsBachelor's in Computer Science, Data Management, or related field; familiarity with data validation toolsBachelor's in Data Science, Statistics, or related; certifications like CDMP are common
Work EnvironmentData teams, software development, quality assuranceData analysis, reporting, data governance teams
Industry UsageTech, finance, healthcare, where data validation is criticalBusiness intelligence, analytics, data management sectors

The Csv Validation Engineer primarily focuses on validating and ensuring the accuracy of CSV data files through automated tools and scripts. In contrast, the Data Quality Analyst evaluates overall data quality, identifies issues, and implements data governance practices. Both roles require strong analytical skills and familiarity with data management, but their core responsibilities differ in scope and focus.

What are popular job titles related to Csv Validation Engineer jobs in Michigan? For Csv Validation Engineer jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Csv Validation Engineer jobs in Michigan look for? The top searched job categories for Csv Validation Engineer jobs in Michigan are:
What cities in Michigan are hiring for Csv Validation Engineer jobs? Cities in Michigan with the most Csv Validation Engineer job openings:
Csv Validation Engineer jobs near you
Infographic showing various Csv Validation Engineer job openings in Michigan as of July 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution, with an average salary of $92,925 per year, or $44.7 per hour.

Head of Validation

Biovire

Brighton, MI • On-site

Full-time

Medical, Dental, Vision, Life, PTO

Re-posted 13 days ago

Job description

Manager, 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, Validation, reporting to the VP, Engineering, 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, 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, Operations, Manufacturing, Engineering, Maintenance, and cross-functional operational teams to ensure all systems remain compliant, qualified, and inspection-ready.

Key Responsibilities

  • Lead enterprise validation programs supporting equipment, facilities, utilities, automation, and computerized systems across Biovire's GMP manufacturing operations.
  • Oversee commissioning, qualification, and the overall validation strategy and activities.
  • Partner with Operations and Quality to maintain the qualified state of manufacturing systems.
  • Support commercialization, technology transfer, process validation, and startup activities for new manufacturing processes and facilities.
  • Serve as Validation SME during FDA and regulatory inspections.
  • Lead lifecycle management of validation systems.
  • 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
  • Experience interacting with FDA or other regulatory agencies and supporting inspections.
  • Ability to communicate technical validation concepts during inspections.
  • 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.