Global Process Engineer (Aseptic)

Location: North Chicago, Illinois, United States

Salary: $124,500–$236,500 per year

Company

hirify.global develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Support global technical operations and technical centers on aseptic capital projects and process troubleshooting.
• Lead or contribute to projects involving aseptic equipment selection, process updates, and advanced processing technologies.
• Develop engineering solutions through sound design, early risk assessments, implementation strategies, and failure-mode analysis.
• Provide technical direction to operating sites and cross-functional teams, including advice to management.
• Evaluate engineering advances and resolve operating issues while considering business and commercial requirements.
• Present project results internally and externally and ensure timely completion and compliance with applicable policies.

Requirements

• MS or PhD in Mechanical Engineering, Chemical Engineering, or a related field.
• 6–8 years of engineering experience in pharmaceutical aseptic process design, equipment selection, and operation.
• Expertise in aseptic processing, upstream or downstream biological processing, or aseptic fill-finish operations.
• Knowledge of fill-finish technology, cleanroom design, utilities, microbial control, environmental monitoring, SCADA, MES, and equipment control systems.
• Experience with FMEA, risk assessments, investigations, change control, high-containment processing, cleaning and sanitization, and project costing.
• Demonstrated subject-matter expertise, negotiation skills, and the ability to reconcile differences.

Nice to have

• Knowledge of lyophilization, Blow-Fill-Seal, single-use systems, secondary packaging, robotics, and related pharmaceutical technologies.
• Familiarity with ISPE, ASME, ISO, and USP literature and regulatory requirements in Europe and the United States.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.