Director, Engineering, Technical Expert Sterile Fill

Job Description

Position Summary

The Director Engineering Technical Expert Sterile Fill provides enterprise-level technical leadership for sterile fill engineering across AbbVie’s strategic investment portfolio, with accountability for biologics sterile filling, Annex 1-aligned contamination control, aseptic processing design, barrier technology strategy, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance within Strategic Investments - Engineering.

The role shapes and governs engineering strategies for strategic investments by setting technical direction, aligning standards and assuring robust execution across priority capital programs, technology platforms and future manufacturing capabilities.

The role leads engineering activities associated with strategic investment programs, including new facility investments, technology platform deployments, capacity expansion, infrastructure enablement, lifecycle asset renewal and capability-building initiatives that materially impact long-term business performance.

The role partners with Strategic Investments leadership, operating sites, quality, EHS, validation / CQV and external engineering partners to make high-quality technical decisions, resolve complex risks and deliver business-aligned engineering outcomes.

Strategic Investments - Engineering Context

Strategic Investments - Engineering provides senior technical leadership, engineering governance, standards ownership and execution assurance across AbbVie’s strategic investment portfolio.

The organization supports strategic capital programs including new manufacturing facilities, technology platform deployments, capacity expansion, infrastructure enablement, lifecycle asset renewal and future capability investments.

Strategic Investments - Engineering roles are expected to establish clear technical direction, drive enterprise alignment, transfer lessons learned and enable consistent, high-quality engineering delivery across the strategic investment portfolio.

Key Responsibilities

Strategic Investments - Engineering Governance and Standards

• Establish, maintain and deploy global engineering standards, technical practices and governance expectations for biologics sterile fill engineering, Annex 1-aligned contamination control strategy, aseptic processing, barrier technologies, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance.
• Drive consistent application of technical standards, design principles, lessons learned and engineering playbooks across regions, sites and capital projects.
• Ensure discipline strategies directly support AbbVie’s strategic investment priorities, future manufacturing capability requirements and major capital program objectives.
• Provide governance and escalation for technical decisions with material safety, quality, compliance, cost, schedule, operability or lifecycle impact.

Strategic Investment Leadership and Execution Support

• Provide senior engineering leadership for strategic capital investments, including new facility builds, technology platform deployments, capacity projects, 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 activities.
• Partner with Strategic Investments and project leadership to ensure technical assumptions, deliverables, risks and resource needs are integrated into capital program plans.
• Apply enterprise lessons learned and strategic investment standards to improve project quality, decision speed, reliability and readiness across the portfolio.

Sterile Filling, Biologics Manufacturing and Annex 1 Compliance

• Provide senior technical leadership for sterile filling of biologics and parenteral products, including vial, syringe, cartridge and bulk sterile transfer interfaces where relevant to strategic investment scope.
• Ensure facility, equipment and process design decisions are aligned with EU GMP Annex 1 expectations for sterile medicinal products, including contamination control strategy, quality risk management, cleanroom classification, barrier technology and aseptic process control.
• Govern technical strategy for isolators, restricted access barrier systems, Grade A critical zones, Grade B / C / D background environments, unidirectional airflow, first-air protection, glove systems, transfer systems and aseptic interventions.
• Lead engineering input to contamination control strategy development, ensuring critical control points are embedded across facility design, equipment, utilities, personnel flows, material flows, cleaning, disinfection, environmental monitoring and maintenance access.

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