Senior Validation Leader – CQV/CSV for GMP Systems

Biovire, Inc.; Michigan; On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Company-paid medical, dental, vision,

life insurance

Paid Time Off

Job summary

Biovire, Inc. in Brighton, Michigan, seeks a Manager of Validation to lead comprehensive CQV and CSV programs for equipment, facilities, utilities, and computerized systems in a regulated pharmaceutical environment.

The role ensures validation readiness, supports inspections, and maintains lifecycle management across manufacturing systems, partnering with Quality, Manufacturing, Engineering and Maintenance.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 5+ years in pharmaceutical or regulated manufacturing environments.
• Leadership experience within Validation, CQV, or Quality functions.
• Strong understanding of cGMP, validation lifecycle management, and 21 CFR Part 11.

Responsibilities

• Lead site validation programs covering equipment, facilities, utilities and computerized systems.
• Oversee CQV/CSV activities in line with cGMP requirements and validation plans.
• Maintain Validation Master Plans and lifecycle documentation throughout projects.
• Plan, schedule, review, and execute validation activities with cross-functional teams.
• Support transition of equipment and systems from Engineering to operations.
• Collaborate with Quality, Manufacturing, Engineering and Maintenance teams.
• Provide guidance for risk assessments, change controls, deviations and investigations.
• Ensure timely completion of validation protocols, reports and IQ/OQ documents.
• Support audit and inspection readiness; develop validation personnel and culture.

Skills

Leadership

CQV

CSV

cGMP

21 CFR Part 11

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Science, Computer Systems, or related technical field

Job description

Biovire, Inc. in Brighton, Michigan, seeks a Manager of Validation to lead comprehensive CQV and CSV programs for equipment, facilities, utilities, and computerized systems in a regulated pharmaceutical environment.

The role ensures validation readiness, supports inspections, and maintains lifecycle management across manufacturing systems, partnering with Quality, Manufacturing, Engineering and Maintenance.