{"id":3545846,"url":"https://alion.io/job/abbvie-director-engineering-technical-expert-sterile-fill-3","title":"Director, Engineering, Technical Expert Sterile Fill","company":{"id":3660,"name":"AbbVie","domain":"abbvie.com","url":"https://alion.io/company/abbvie","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":80,"open_postings":77,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":16,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Chicago, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":160500,"max":305000,"currency":"USD","period":"year","gross":null,"usd_annual":305000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-30T19:43:21Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-03T14:37:53Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"About AbbVie\nAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.\n Position Summary\nThe 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.\nThe 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.\nThe 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.\nThe 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.\nStrategic Investments - Engineering Context\nStrategic Investments - Engineering provides senior technical leadership, engineering governance, standards ownership and execution assurance across AbbVie’s strategic investment portfolio.\nThe organization supports strategic capital programs including new manufacturing facilities, technology platform deployments, capacity expansion, infrastructure enablement, lifecycle asset renewal and future capability investments.\nStrategic 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.\nKey Responsibilities\nStrategic Investments - Engineering Governance and Standards\nEstablish, 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.\nDrive consistent application of technical standards, design principles, lessons learned and engineering playbooks across regions, sites and capital projects.\nEnsure discipline strategies directly support AbbVie’s strategic investment priorities, future manufacturing capability requirements and major capital program objectives.\nProvide governance and escalation for technical decisions with material safety, quality, compliance, cost, schedule, operability or lifecycle impact.\nStrategic Investment Leadership and Execution Support\nProvide 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.\nSupport front-end engineering, facility concept development, investment option evaluation, manufacturing capability assessments and site / platform planning activities.\nPartner with Strategic Investments and project leadership to ensure technical assumptions, deliverables, risks and resource needs are integrated into capital program plans.\nApply enterprise lessons learned and strategic investment standards to improve project quality, decision speed, reliability and readiness across the portfolio.\nSterile Filling, Biologics Manufacturing and Annex 1 Compliance\nProvide 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.\nEnsure 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.\nGovern 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.\nLead 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.\nPartner 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.\nProvide 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.\nEnsure sterile fill investment programs are designed for inspection readiness, robust contamination prevention, operational maintainability, product sterility assurance and reliable long-term biologics manufacturing performance.\nTechnical Leadership and Delivery\nLead 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.\nEnsure engineering deliverables support safety, quality, compliance, operability, maintainability, reliability, sustainability and operational readiness.\nCoordinate technical input from project teams, site SMEs, external engineering partners, vendors and cross-functional stakeholders.\nDrive timely resolution of technical issues and ensure disciplined escalation when decisions have material project, portfolio, enterprise or business impact.\nCross-Functional Integration\nPartner with Strategic Investments, manufacturing operations, quality, validation / CQV, EHS, site engineering, MS&T, supply chain, finance and related engineering disciplines.\nEnsure discipline decisions are integrated with strategic investment objectives, manufacturing strategy, capacity planning, technology platform deployment, regulatory expectations and site handover needs.\nFacilitate collaboration across regions, sites and project teams to avoid fragmented solutions and drive consistency across strategic investments.\nRepresent Strategic Investments - Engineering in technical reviews, project forums and risk discussions relevant to assigned scope.\nCapability Building and Continuous Improvement\nShare engineering best practices, lessons learned and technical knowledge across sites, regions and projects.\nBuild capability through coaching, mentoring, technical review discipline and development of reusable engineering practices.\nPromote a culture of engineering excellence, safety, quality, reliability, collaboration, accountability and proactive risk management.\nSupport continuous improvement of Strategic Investments - Engineering standards, templates, knowledge management and project delivery approaches.\nStrategic Investments - Engineering Leadership Expectations\nCollaborate across the enterprise engineering community to identify, develop and deploy best practices, technical standards, lessons learned and capability-building initiatives.\nPromote consistency, quality, reliability, sustainability and project delivery performance across the strategic investment portfolio.\nSupport long-range strategic investment planning, manufacturing strategy and future capability development.\nBuild technical capability through coaching, mentoring, standards governance, knowledge management and cross-functional collaboration.\nStakeholder Interfaces\nStrategic Investments: Investment planning, portfolio alignment, technical assumptions, front-end engineering, strategic capital program support and executive decision enablement.\nManufacturing Sites and Operations: Network needs, site readiness, operability, maintainability, startup, handover and operational performance support.\nQuality, Validation / CQV and EHS: Compliance expectations, validation strategy, qualification readiness, safety, risk review and inspection readiness interfaces.\nStrategic Investments - Engineering Disciplines: Cross-discipline technical integration, standards, design reviews, technical issue resolution and strategic investment lessons learned.\nExternal Engineering Partners, EPCM Firms, Vendors and OEMs: Technical oversight, deliverable review, issue escalation, supplier alignment and execution quality.\n Bachelor’s degree in Engineering, Science or a relevant technical discipline required; advanced degree preferred where relevant.\nTypically 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations or regulated manufacturing experience.\nDemonstrated 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.\nExperience supporting pharmaceutical, biopharmaceutical, medical device, API, peptides, biologics, sterile or similarly regulated manufacturing environments preferred.\nDemonstrated ability to operate across global functions, strategic investment teams, manufacturing sites, project teams, suppliers, vendors and external engineering partners.\nStrong communication, risk management, technical judgment, stakeholder engagement and structured problem-solving skills.\nTechnical Competencies\nBiologics sterile fill-finish systems\nEU GMP Annex 1 contamination control strategy, aseptic processing and sterility assurance\nEquipment / facility interfaces\nStrategic investment portfolio support\nStrategic investment manufacturing readiness and sterile operations support\nStrategic capital investment leadership\nEngineering governance and standards\nTechnical risk management\nProject execution support\nStakeholder management\nVendor / partner technical coordination\nGMP and regulated manufacturing awareness\nIsolator / RABS design, Grade A critical zones, background classification and aseptic intervention strategy\nOperational readiness and handover support\nLeadership Competencies\nStrategic thinking and enterprise mindset\nMatrix leadership and influence without direct authority\nClear technical communication and executive-ready recommendations\nRisk-based decision making and issue escalation\nCollaboration across functions, sites, regions and external partners\nCapability building, mentoring and knowledge sharing\nContinuous improvement and commitment to safety, quality and compliance\nWorking Relationships\nThis role works globally with Strategic Investments, Strategic Investments - Engineering disciplines, manufacturing sites, quality, validation / CQV, EHS, 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