Director, Engineering, Technical Expert – Sterile Fill

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Deliver enterprise-level technical guidance for sterile fill engineering within AbbVie's strategic investment portfolio.

• Develop, uphold, and implement global engineering standards, technical practices, and governance expectations.

• Oversee engineering initiatives for new facilities, technology platform implementations, capacity enhancements, infrastructure support, lifecycle asset renewal, and future capability investments.

• Assist in front-end engineering, facility concept formulation, investment option assessment, manufacturing capability evaluations, and site/platform planning.

• Offer technical leadership for biologics and parenteral sterile filling, including vial, syringe, cartridge, and bulk sterile transfer interfaces.

• Ensure that facility, equipment, and process designs comply with EU GMP Annex 1 and contamination control standards.

• Manage strategy for isolators, RABS, Grade A critical zones, cleanroom environments, airflow systems, glove systems, transfer systems, and aseptic interventions.

• Lead engineering contributions to the contamination control strategy, covering facility design, equipment, utilities, personnel/material flows, cleaning, disinfection, environmental monitoring, and maintenance access.

• Collaborate with Quality, MS&T, Validation/CQV, and Operations on media fills, filter integrity evaluations, sterile filtration, container closure integrity, environmental monitoring, and particle control.

• Promote technical decision-making, risk resolution, escalation, and technical assurance across strategic investment initiatives.

• Synchronize technical input from project teams, site SMEs, external engineering partners, vendors, and interdisciplinary stakeholders.

• Partner with Strategic Investments, manufacturing operations, Quality, Validation/CQV, EHS, site engineering, MS&T, supply chain, finance, and associated engineering fields.

• Exchange best practices, lessons learned, and technical expertise; enhance capability through coaching, mentoring, and reusable engineering practices.

• Contribute to long-range strategic investment planning, manufacturing strategy, future capability development, standards governance, and continuous improvement.

⛳️ Requirements

• A Bachelor's degree in Engineering, Science, or a related technical field is mandatory.

• Typically possesses 12 to 15 years of pertinent engineering, manufacturing, capital project, technical operations, or regulated manufacturing experience.

• Demonstrates technical proficiency in biologics sterile filling, aseptic processing, Annex 1 contamination control requirements, 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 settings is preferred.

• Capable of operating across global functions, strategic investment teams, manufacturing sites, project teams, suppliers, vendors, and external engineering partners.

• Strong communication, risk management, technical acumen, stakeholder engagement, and structured problem-solving abilities.

• Familiarity with biologics sterile fill-finish systems.

• Understanding of EU GMP Annex 1 contamination control strategy, aseptic processing, and sterility assurance.

• Knowledgeable in equipment/facility interfaces and strategic capital investment leadership.

• Experienced 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) plan.

• Long-term incentive programs.

• Travel opportunity (20% of the time).