CQV Project Manager (Biotech)

Location: Minneapolis, United States

Company

hirify.global provides consulting and technical services for the development, manufacturing, and distribution of healthcare products in regulated life sciences environments.

What you will do

• Lead commissioning, qualification, and validation activities for facility, utility, equipment, automation, and process implementation projects.
• Develop and manage project schedules, resource plans, budget forecasts, and execution strategies.
• Coordinate multidisciplinary teams across engineering, quality, manufacturing, validation, automation, maintenance, and external vendors.
• Oversee protocol development, field execution, discrepancy resolution, validation deliverables, and final reports.
• Track project progress, manage risks and mitigation plans, and provide status updates to stakeholders and leadership.
• Support startup, shutdown, operational readiness, change management, quality systems, and project closeout activities.

Requirements

• Bachelor’s degree in engineering, biotechnology, life sciences, pharmaceutical sciences, or a related technical discipline.
• 8+ years of experience in the pharmaceutical, biotechnology, medical device, or life sciences industry.
• 3+ years of experience leading CQV, validation, engineering, or capital project teams.
• Demonstrated experience delivering commissioning, qualification, validation, startup, or lifecycle management projects in regulated manufacturing environments.
• Hands-on experience managing CQV programs with Kneat Gx digital validation systems.
• Experience with facility expansions, technology transfers, new product introductions, or manufacturing process improvements.

Nice to have

• Experience with biologics, aseptic processing, cell culture, or protein manufacturing.

Culture & Benefits

• Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• Employee assistance programs, life insurance, short- and long-term disability coverage, and other insurance options.
• 401(k) plan with matching.
• Paid time off, sick time, and paid holidays.
• Education assistance, pet insurance, fitness perks, and financial discounts.