Director, Engineering, Technical Expert – Sterile Fill

AbbVie

. Provide enterprise-level technical leadership for sterile fill engineering across AbbVie's strategic investment portfolio .

Posted 10/30/2026full-timeRemote • Illinois • United StatesLead💰 $160,500 - $305,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive technical leadership in biologics sterile filling and aseptic processing, ensuring compliance with EU GMP Annex 1 and contamination control standards. Capable of driving strategic investment planning and fostering collaboration across global functions and engineering disciplines.

Highest-signal resume keywords

Biologics Sterile FillingAseptic ProcessingEU GMP Annex 1 ComplianceTechnical Risk ManagementEngineering Governance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Sterile FiltrationEnvironmental MonitoringValidation/CQV IntegrationIsolator/RABS DesignProject ExecutionManufacturing Capability AssessmentTechnical AssuranceContamination Control StrategyFacility DesignCapital Project Management

Soft Skills

Strong CommunicationStakeholder EngagementStructured Problem-SolvingRisk ManagementTechnical Judgment

Industry Keywords

Pharmaceutical ManufacturingBiopharmaceuticalsMedical DevicesRegulated ManufacturingAPIPeptidesCleanroom InterfacesGrade A Critical ZonesAseptic Intervention StrategyOperational Readiness

Tech Stack

Tools & technologies

Airflow

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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)