Director, Engineering, Technical Expert – Sterile Fill

🔥 13 hours ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $160.5k - $305k / year

⏰ Full Time

🔴 Lead

🖥 Software Engineer

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Provide enterprise-level technical leadership for sterile fill engineering across AbbVie's strategic investment portfolio • Establish, maintain, and deploy global engineering standards, technical practices, and governance expectations • Lead engineering activities for new facilities, technology platform deployments, capacity expansion, infrastructure enablement, lifecycle asset renewal, and future capability investments • Support front-end engineering, facility concept development, investment option evaluation, manufacturing capability assessments, and site/platform planning • Provide technical leadership for biologics and parenteral sterile filling, including vial, syringe, cartridge, and bulk sterile transfer interfaces • Ensure facility, equipment, and process designs align with EU GMP Annex 1 and contamination control requirements • Govern strategy for isolators, RABS, Grade A critical zones, cleanroom backgrounds, airflow, glove systems, transfer systems, and aseptic interventions • Lead engineering input to contamination control strategy, including facility design, equipment, utilities, personnel/material flows, cleaning, disinfection, environmental monitoring, and maintenance access • Partner with Quality, MS&T, Validation/CQV, and Operations on media fills, filter integrity testing, sterile filtration, container closure integrity, environmental monitoring, and particle control • Drive technical decision-making, risk resolution, escalation, and technical assurance across strategic investment programs • Coordinate technical input from project teams, site SMEs, external engineering partners, vendors, and cross-functional stakeholders • Partner with Strategic Investments, manufacturing operations, Quality, Validation/CQV, EHS, site engineering, MS&T, supply chain, finance, and related engineering disciplines • Share best practices, lessons learned, and technical knowledge; build capability through coaching, mentoring, and reusable engineering practices • Support long-range strategic investment planning, manufacturing strategy, future capability development, standards governance, and continuous improvement

🎯 Requirements

• Bachelor's degree in Engineering, Science, or a relevant technical discipline required • Typically 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations, or regulated manufacturing experience • Technical capability in biologics sterile filling, aseptic processing, Annex 1 contamination control expectations, isolators/RABS, cleanroom interfaces, sterile filtration, environmental monitoring, GMP readiness, validation/CQV integration, and technical assurance • Experience in pharmaceutical, biopharmaceutical, medical device, API, peptides, biologics, sterile, or similarly regulated manufacturing environments preferred • Ability to operate across global functions, strategic investment teams, manufacturing sites, project teams, suppliers, vendors, and external engineering partners • Strong communication, risk management, technical judgment, stakeholder engagement, and structured problem-solving skills • Knowledge of biologics sterile fill-finish systems • Knowledge of EU GMP Annex 1 contamination control strategy, aseptic processing, and sterility assurance • Knowledge of equipment/facility interfaces and strategic capital investment leadership • Experience with engineering governance, standards, technical risk management, project execution, vendor coordination, GMP, isolator/RABS design, Grade A critical zones, background classification, aseptic intervention strategy, operational readiness, and handover support

🏖️ Benefits

• Paid time off including vacation, holidays, and sick leave • Medical, dental, and vision insurance • 401(k) • Long-term incentive programs • Travel opportunity (20% of the time)

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