Director, Engineering, Technical Expert Sterile Fill

AbbVie•Durham, NC

6d•$160,500 - $305,000

About The Position

The Director Engineering Technical Expert Sterile Fill provides enterprise-level technical leadership for sterile fill engineering across AbbVie’s strategic investment portfolio. The role is accountable for biologics sterile filling, Annex 1-aligned contamination control, aseptic processing design, barrier technology strategy, equipment and facility interfaces, GMP readiness, validation / CQV integration, and technical assurance within Strategic Investments - Engineering. The position sets and governs engineering strategies for strategic investments by establishing technical direction, aligning standards, and assuring execution across priority capital programs, technology platforms, and future manufacturing capabilities. It leads engineering activities for new facility investments, technology deployments, capacity expansion, infrastructure enablement, lifecycle asset renewal, and capability-building initiatives. The role partners with Strategic Investments leadership, manufacturing sites, Quality, EHS, Validation / CQV, Operations, MS&T, Supply Chain, Finance, and external engineering partners. It makes and supports high-quality technical decisions, resolves complex risks, and delivers business-aligned engineering outcomes. The role operates globally across multiple programs and platforms, strengthening technical governance and enabling high-quality capital delivery.

Requirements

Bachelor’s degree in Engineering, Science, or a relevant technical discipline.
Typically 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations, or regulated manufacturing experience.
Demonstrated 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.
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.
Technical knowledge of biologics sterile fill-finish systems, sterility assurance, equipment / facility interfaces, strategic investment portfolio support, capital investment leadership, engineering governance and standards, technical risk management, project execution support, vendor coordination, regulated manufacturing, operational readiness, and handover.
Leadership skills in strategic thinking, enterprise mindset, matrix leadership, influence without direct authority, clear technical communication, risk-based decision-making, issue escalation, cross-functional collaboration, capability building, mentoring, knowledge sharing, and continuous improvement.

Nice To Haves

An advanced degree where relevant.
Experience supporting pharmaceutical, biopharmaceutical, medical device, API, peptide, biologics, sterile, or similarly regulated manufacturing environments.

Responsibilities

Establish, maintain, and deploy global engineering standards, technical practices, and governance expectations for biologics sterile fill engineering, Annex 1-aligned contamination control, 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 support strategic investment priorities, future manufacturing capabilities, and major capital program objectives.
Provide governance and escalation for technical decisions with material safety, quality, compliance, cost, schedule, operability, or lifecycle impact.
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.
Integrate technical assumptions, deliverables, risks, and resource needs into capital program plans with Strategic Investments and project leadership.
Apply enterprise lessons learned and strategic investment standards to improve project quality, decision speed, reliability, and readiness.
Provide senior technical leadership for sterile filling of biologics and parenteral products, including vial, syringe, cartridge, and bulk sterile transfer interfaces where relevant.
Ensure facility, equipment, and process design decisions align with EU GMP Annex 1 expectations, 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, embedding critical control points across facility design, equipment, utilities, personnel and material flows, cleaning, disinfection, environmental monitoring, and maintenance access.
Partner with Quality, MS&T, Validation / CQV, and Operations to consider aseptic process simulations, media fill strategy, filter integrity testing, sterile filtration, container closure integrity, environmental monitoring, and particle control 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.
Ensure sterile fill investment programs support inspection readiness, contamination prevention, maintainability, product sterility assurance, and reliable long-term biologics manufacturing performance.
Lead technical decision-making for sterile fill engineering and associated aseptic processing, Annex 1 compliance, contamination control, barrier technology, equipment / facility interfaces, GMP readiness, validation / CQV integration, and technical assurance.
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 disciplined escalation when decisions have material project, portfolio, enterprise, or business impact.
Partner with Strategic Investments, manufacturing operations, Quality, Validation / CQV, EHS, site engineering, MS&T, Supply Chain, Finance, and related engineering disciplines.
Integrate discipline decisions with investment objectives, manufacturing strategy, capacity planning, technology deployment, regulatory expectations, and site handover needs.
Facilitate collaboration across regions, sites, and project teams to prevent fragmented solutions and promote consistency across strategic investments.
Represent Strategic Investments - Engineering in technical reviews, project forums, and relevant risk discussions.
Share engineering best practices, lessons learned, and technical knowledge across sites, regions, and projects.
Build capability through coaching, mentoring, technical review discipline, and reusable engineering practices.
Promote engineering excellence, safety, quality, reliability, collaboration, accountability, and proactive risk management.
Support continuous improvement of engineering standards, templates, knowledge management, and project delivery approaches.
Collaborate across the enterprise engineering community to develop and deploy best practices, technical standards, lessons learned, and capability-building initiatives.
Support long-range strategic investment planning, manufacturing strategy, and future capability development.