CQV Project Lead for GMP Biotech Manufacturing

PSC Biotech; Minneapolis (MN); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Medical insurance

401(k) matching

PTO & holidays

Education assistance

Pet insurance

Fitness perks

Discount programs

Job summary

PSC Biotech is seeking an experienced CQV Project Manager to lead commissioning, qualification, and validation activities for complex pharmaceutical and biotechnology manufacturing projects in GMP environments.

You will oversee multidisciplinary teams, develop schedules and budgets, manage cross-functional coordination, and ensure regulatory compliance from initiation through operational readiness and closeout.

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or related discipline.
• 8+ years in pharma/biotech/medical devices/life sciences.
• 3+ years leading CQV/validation/engineering/capital projects.
• Experience delivering commissioning, qualification, validation, startup, lifecycle projects in regulated manufacturing.
• Hands-on CQV experience with Kneat Gx digital validation systems.
• Experience with large-scale facility expansions, tech transfers, new product introductions.
• Biologics/aseptic/cell culture/protein manufacturing preferred.

Responsibilities

• Lead CQV activities for facility, utility, equipment, automation, and process implementation.
• Develop and manage project schedules, resource plans, budgets, and execution strategies.
• Coordinate cross-functional teams: engineering, quality, manufacturing, validation, automation, and vendors.
• Oversee protocol development, field execution, and final report completion.
• Monitor progress, identify risks, and implement mitigation plans to meet milestones.
• Manage validation deliverables in line with quality/regulatory requirements.
• Facilitate project meetings and provide status updates to stakeholders.

Skills

CQV project management

Validation engineering

Capital projects

Education

Bachelor's degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related technical discipline

Tools

Kneat Gx

Job description

PSC Biotech is seeking an experienced CQV Project Manager to lead commissioning, qualification, and validation activities for complex pharmaceutical and biotechnology manufacturing projects in GMP environments.

You will oversee multidisciplinary teams, develop schedules and budgets, manage cross-functional coordination, and ensure regulatory compliance from initiation through operational readiness and closeout.