Project Engineer (Biotech)

Location: Boulder, United States; must be authorized to work in the U.S.

Salary: $100,000–$120,000 per year

Company

hirify.global provides engineering and life sciences services supporting the development, manufacturing, and distribution of healthcare products in regulated environments.

What you will do

• Lead engineering projects from requirements definition and design through procurement, installation, commissioning, qualification, and closeout.
• Develop project scopes, schedules, budgets, resource plans, and implementation strategies.
• Coordinate projects involving manufacturing equipment, clean utilities, facilities, laboratories, automation, and infrastructure.
• Prepare and review engineering specifications, drawings, assessments, vendor documentation, commissioning records, and turnover packages.
• Coordinate vendors, contractors, engineering service providers, field activities, equipment installation, and system turnover.
• Monitor scope, schedule, budget, quality, safety, risks, change control, startup, troubleshooting, and operational readiness.

Requirements

• Bachelor’s degree in chemical, mechanical, electrical, biomedical, biochemical, or another relevant engineering discipline.
• 5+ years of experience in pharmaceutical, biotechnology, biologics, cell and gene therapy, medical device, or another FDA-regulated manufacturing environment.
• Demonstrated experience executing engineering projects in a GMP-regulated facility.
• Knowledge of project lifecycle activities, GMP documentation, change control, deviations, CAPA, and controlled engineering documentation.
• Experience working with Manufacturing, Quality Assurance, Validation, Automation, Facilities, Maintenance, EHS, vendors, contractors, and engineering firms.
• Must be authorized to work in the U.S.; C2C arrangements are not available.

Nice to have

• Experience with biopharmaceutical or biologics manufacturing facilities, process equipment, clean utilities, and controlled manufacturing environments.
• Familiarity with commissioning and qualification practices, risk-based qualification, FDA cGMP, 21 CFR Parts 210/211, ISPE guidance, and GAMP principles.
• Experience supporting capital projects, facility expansions, equipment upgrades, technology transfers, or manufacturing capacity expansions.
• Project management certification or formal project management training.

Culture & Benefits

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