Project Engineer III, Pharmaceutical Manufacturing

Location: Irvine, California, United States; onsite manufacturing environment

Salary: $125,000–$135,000 per year

Company

hirify.global is a global pharmaceutical CDMO that develops and manufactures active pharmaceutical ingredients and finished dosage forms across a network of international sites.

What you will do

• Lead CAPEX projects involving facility expansions, utility upgrades, equipment installations, and manufacturing process improvements.
• Manage projects from concept through commissioning, qualification, validation, and operational handoff.
• Develop project plans, budgets, schedules, and risk mitigation strategies.
• Coordinate contractors, vendors, OEMs, and cross-functional stakeholders from Manufacturing, Quality, Validation, and Facilities.
• Lead FAT, SAT, and CQV activities, including URS, DQ, IQ, OQ, and PQ documentation.
• Support new product introductions, process optimization, equipment lifecycle management, root cause investigations, CAPAs, and continuous improvement.

Requirements

• Bachelor’s degree in Mechanical, Chemical, Industrial, Pharmaceutical, or related Engineering discipline.
• 4+ years of engineering experience in pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• 2+ years of direct Commissioning, Qualification, and Validation experience.
• Proven experience managing CAPEX projects and implementing manufacturing equipment.
• Strong understanding of GMP manufacturing, validation, quality systems, and FDA requirements.
• Experience working in cleanroom environments.

Nice to have

• Experience in a CDMO environment.
• Experience supporting new product introductions and manufacturing scale-up.
• Experience working directly with vendors, contractors, and regulatory auditors.

Culture & Benefits

• Collaborative environment focused on safety, quality, sustainability, and professional growth.
• Medical, dental, and vision insurance.
• Flexible Spending Account and HSA options.
• Life insurance, short- and long-term disability coverage, and pet insurance.
• 401(k) plan.