Senior CQV Project Leader - GMP Validation & Commissioning

biotech; Minneapolis (MN); On-site; USD 140,000 - 175,000; Full time

Benefits offered by this job

Medical premiums fully covered for you

401(k) matching

Paid time off & holidays

Education assistance

Pet Insurance

Job summary

PSC Biotech is seeking an experienced CQV Project Manager to lead commissioning, qualification, and validation activities for complex biopharma projects. You will manage multidisciplinary teams and coordinate with engineering, quality, and operations to ensure safe, compliant, and timely project delivery.

The ideal candidate has extensive CQV experience in regulated manufacturing, with strong leadership, planning, and risk management skills, and will drive project success from initiation to

Qualifications

• <Requirement> Bachelor’s degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
• <Requirement> 8+ years in pharma/biotech/life sciences.
• <Requirement> 3+ years leading CQV/validation/engineering teams.

Responsibilities

• Lead CQV activities supporting facility, utility, equipment, automation and process implementation projects.
• Develop and manage project schedules, resource plans, budgets, and execution strategies.
• Coordinate cross-functional teams across engineering, quality, manufacturing, validation, automation, and vendors.
• Provide oversight for protocol development, field execution, discrepancy resolution, and final report completion.
• Monitor progress, identify risks, and implement mitigation plans to meet milestones.
• Ensure compliance with GMP standards and regulatory requirements throughout the project lifecycle.

Skills

Project management

CQV expertise

Cross-functional leadership

Regulatory compliance

Risk management

Communication

Education

Bachelor's degree in Engineering/Life Sciences/Pharmaceutical Sciences

Tools

Kneat Gx

Job description

PSC Biotech is seeking an experienced CQV Project Manager to lead commissioning, qualification, and validation activities for complex biopharma projects. You will manage multidisciplinary teams and coordinate with engineering, quality, and operations to ensure safe, compliant, and timely project delivery.

The ideal candidate has extensive CQV experience in regulated manufacturing, with strong leadership, planning, and risk management skills, and will drive project success from initiation to