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.
- Partner with Quality, MS&T, Validation / CQV and Operations to ensure aseptic process simulations, media fill strategy, filter integrity testing, sterile filtration, container closure integrity, environmental monitoring and viable / non-viable particle control are considered in design and readiness decisions.
- Provide technical challenge and risk-based decision support for interventions, line set-up, lyophilization interfaces, stopper / component handling, depyrogenation, sterilization, single-use systems, CIP / SIP interfaces and biologics product protection requirements.
- Ensure sterile fill investment programs are designed for inspection readiness, robust contamination prevention, operational maintainability, product sterility assurance and reliable long-term biologics manufacturing performance.
Technical Leadership and Delivery
- Lead technical decision-making for biologics sterile fill engineering, aseptic processing design, Annex 1 compliance expectations, contamination control strategy, barrier technology selection, equipment / facility interfaces, GMP readiness, validation / CQV integration and technical assurance across strategic investment programs and technology platforms.
- Ensure engineering deliverables support safety, quality, compliance, operability, maintainability, reliability, sustainability and operational readiness.
- Coordinate technical input from project teams, site SMEs, external engineering partners, vendors and cross-functional stakeholders.
- Drive timely resolution of technical issues and ensure disciplined escalation when decisions have material project, portfolio, enterprise or business impact.
Cross-Functional Integration
- Partner with Strategic Investments, manufacturing operations, quality, validation / CQV, EHS, site engineering, MS&T, supply chain, finance and related engineering disciplines.
- Ensure discipline decisions are integrated with strategic investment objectives, manufacturing strategy, capacity planning, technology platform deployment, regulatory expectations and site handover needs.
- Facilitate collaboration across regions, sites and project teams to avoid fragmented solutions and drive consistency across strategic investments.
- Represent Strategic Investments - Engineering in technical reviews, project forums and risk discussions relevant to assigned scope.
Capability Building and Continuous Improvement
- Share engineering best practices, lessons learned and technical knowledge across sites, regions and projects.
- Build capability through coaching, mentoring, technical review discipline and development of reusable engineering practices.
- Promote a culture of engineering excellence, safety, quality, reliability, collaboration, accountability and proactive risk management.
- Support continuous improvement of Strategic Investments - Engineering standards, templates, knowledge management and project delivery approaches.
Strategic Investments - Engineering Leadership Expectations
- Collaborate across the enterprise engineering community to identify, develop and deploy best practices, technical standards, lessons learned and capability-building initiatives.
- Promote consistency, quality, reliability, sustainability and project delivery performance across the strategic investment portfolio.
- Support long-range strategic investment planning, manufacturing strategy and future capability development.
- Build technical capability through coaching, mentoring, standards governance, knowledge management and cross-functional collaboration.
Stakeholder Interfaces
Strategic Investments: Investment planning, portfolio alignment, technical assumptions, front-end engineering, strategic capital program support and executive decision enablement.
Manufacturing Sites and Operations: Network needs, site readiness, operability, maintainability, startup, handover and operational performance support.
Quality, Validation / CQV and EHS: Compliance expectations, validation strategy, qualification readiness, safety, risk review and inspection readiness interfaces.
Strategic Investments - Engineering Disciplines: Cross-discipline technical integration, standards, design reviews, technical issue resolution and strategic investment lessons learned.
External Engineering Partners, EPCM Firms, Vendors and OEMs: Technical oversight, deliverable review, issue escalation, supplier alignment and execution quality.