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Director Computer System Validation Csv Jobs in Michigan

Biovire

Head of Validation

Brighton, MI · On-site

... and computer system validation (CSV) activities across the Brighton site. This role provides ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...

Biovire

Head of Validation

Brighton, MI · On-site

... and computer system validation (CSV) activities across the Brighton site. This role provides ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...

Biovire

Head of Validation

Brighton, MI · On-site

... and computer system validation (CSV) activities across the Brighton site. This role provides ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...

BoehringerPRD

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

Deloitte

System Test and Validation Lead

Midland, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Detroit, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Midland, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Detroit, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Midland, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Detroit, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

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Head of Validation

Biovire

Brighton, MI • On-site

Full-time

Medical, Dental, Vision, Life, PTO

Re-posted 17 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.