Senior Project Engineer (Biopharmaceutical Manufacturing)

Location: Onsite at the GMP manufacturing site in Boca Raton, Florida, United States

Company

hirify.global is a biopharmaceutical company manufacturing, developing, and marketing specialty plasma-derived products for the prevention and treatment of infectious diseases.

What you will do

• Manage mid-to-large engineering projects involving cross-functional teams and contractors, including scope, schedules, budgets, resources, and risk management.
• Design, procure, commission, and upgrade process and utility systems and equipment.
• Develop and review process flow diagrams, P&IDs, commissioning plans, load calculations, testing plans, and change-control documentation.
• Lead investigations into process and equipment issues, determine root causes, and implement corrective and preventive actions.
• Use statistical tools to evaluate process capability, predict trends, improve procedures, and increase equipment reliability.
• Support preventive-maintenance planning, troubleshooting, capital expenditure requests, procurement, regulatory audits, and FDA submissions.

Requirements

• Minimum 10 years of engineering experience in a cGMP pharmaceutical or biological manufacturing environment.
• Ability to follow cGMP requirements and procedures with close attention to detail.
• Ability to read and understand blueprints and evaluate applicable regulations.
• Strong mechanical aptitude, maintenance knowledge, problem-solving, analytical, organizational, technical writing, and communication skills.
• Experience balancing multiple assignments in a high-pressure, deadline-driven environment and translating technical concepts for non-technical audiences.
• Advanced knowledge of Microsoft Office, including Word, Excel, and Microsoft Project.

Culture & Benefits

• 401(k) plan with employer match and immediate vesting.
• Medical, vision, life, dental, and pet insurance.
• Company-paid short-term and long-term disability coverage and holidays.
• Three weeks of paid time off during the first year.
• Tuition assistance after the first year.
• Access to Tri-Rail with a free shuttle to the Boca Tri-Rail station.