Director, Engineering, Technical Expert Sterile Fill

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. 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.

Responsibilities

Establish, maintain and deploy global engineering standards, technical practices and governance expectations for biologics sterile fill engineering; 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; 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; Support front-end engineering, facility concept development, investment option evaluation, manufacturing capability assessments and site / platform planning; Partner with Strategic Investments and project leadership to integrate technical assumptions, deliverables, risks and resource needs into capital program plans; Provide senior technical leadership for sterile filling of biologics and parenteral products; Ensure facility, equipment and process design decisions are aligned with EU GMP Annex 1 expectations; 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; Partner with Quality, MS&T, Validation / CQV and Operations on aseptic process simulations, media fill strategy, filter integrity testing, sterile filtration, container closure integrity, environmental monitoring and particle control; Provide technical challenge and risk-based decision support for interventions, line set-up, lyophilization interfaces, depyrogenation, sterilization, single-use systems, CIP / SIP interfaces and biologics product protection; Lead technical decision-making for biologics sterile fill engineering across strategic investment programs and technology platforms; 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; 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 long-range strategic investment planning, manufacturing strategy and future capability development

Requirements

Bachelor's degree in Engineering, Science or a relevant technical discipline required; advanced degree preferred where relevant; 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; Experience supporting pharmaceutical, biopharmaceutical, medical device, API, peptides, biologics, sterile or similarly regulated manufacturing environments preferred; Demonstrated 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

Nice to have

Advanced degree; Experience supporting pharmaceutical, biopharmaceutical, medical device, API, peptides, biologics, sterile or similarly regulated manufacturing environments

Benefits

Comprehensive package of benefits; Paid time off (vacation, holidays, sick); Medical/dental/vision insurance; 401(k) to eligible employees; Eligibility for long-term incentive programs