Director, Engineering, Technical Expert Sterile Fill (Biologics)

Location: North Chicago, Illinois, United States

Salary: $160,500–$305,000 annual base pay

Company

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

What you will do

• Set enterprise engineering standards and governance for biologics sterile fill, aseptic processing, Annex 1 contamination control, barrier technologies, and technical assurance.
• Lead engineering support for new manufacturing facilities, technology platforms, capacity expansions, infrastructure projects, asset renewal, and future capability investments.
• Guide facility, equipment, process, and utility design for isolators, RABS, Grade A critical zones, cleanroom environments, sterile filtration, and aseptic interventions.
• Integrate contamination control, GMP readiness, validation/CQV, media fills, environmental monitoring, container closure integrity, and inspection readiness into investment programs.
• Coordinate technical decisions and risk resolution with Strategic Investments, manufacturing, Quality, EHS, Operations, MS&T, suppliers, vendors, and external engineering partners.
• Build engineering capability through mentoring, technical reviews, lessons learned, standards governance, and continuous improvement.

Requirements

• Bachelor’s degree in Engineering, Science, or a relevant technical discipline.
• Typically 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations, or regulated manufacturing experience.
• Technical expertise in biologics sterile filling, aseptic processing, EU GMP Annex 1 contamination control, isolators/RABS, cleanrooms, sterile filtration, environmental monitoring, GMP readiness, and validation/CQV integration.
• Experience in pharmaceutical, biopharmaceutical, medical device, API, peptide, biologics, sterile, or similarly regulated manufacturing environments.
• Ability to lead across global functions, manufacturing sites, strategic investment teams, project teams, suppliers, and external engineering partners.
• Strong communication, technical judgment, risk management, stakeholder engagement, and structured problem-solving skills.

Nice to have

• Advanced degree in a relevant technical discipline.
• Experience with sterile operations support, operational readiness, handover, and strategic capital investment leadership.

Culture & Benefits

• Cross-functional work across engineering, manufacturing, Quality, validation, EHS, operations, supply chain, finance, and external partners.
• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) and eligibility for long-term incentive programs.
• Focus on safety, quality, reliability, sustainability, collaboration, accountability, and continuous improvement.