Director, Engineering, Technical Expert – Sterile Fill

Job Description:

  • Provide enterprise-level technical leadership for sterile fill engineering across AbbVie's strategic investment portfolio
  • Establish, maintain, and deploy global engineering standards, technical practices, and governance expectations
  • Lead engineering activities for new facilities, technology platform deployments, capacity expansion, 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
  • Provide technical leadership for biologics and parenteral sterile filling, including vial, syringe, cartridge, and bulk sterile transfer interfaces
  • Ensure facility, equipment, and process designs align with EU GMP Annex 1 and contamination control requirements
  • Govern strategy for isolators, RABS, Grade A critical zones, cleanroom backgrounds, airflow, glove systems, transfer systems, and aseptic interventions
  • Lead engineering input to contamination control strategy, including facility design, equipment, utilities, personnel/material flows, cleaning, disinfection, environmental monitoring, and maintenance access
  • Partner with Quality, MS&T, Validation/CQV, and Operations on media fills, filter integrity testing, sterile filtration, container closure integrity, environmental monitoring, and particle control
  • Drive technical decision-making, risk resolution, escalation, and technical assurance across strategic investment programs
  • Coordinate technical input from project teams, site SMEs, external engineering partners, vendors, and cross-functional stakeholders
  • Partner with Strategic Investments, manufacturing operations, Quality, Validation/CQV, EHS, site engineering, MS&T, supply chain, finance, and related engineering disciplines
  • Share best practices, lessons learned, and technical knowledge; build capability through coaching, mentoring, and reusable engineering practices
  • Support long-range strategic investment planning, manufacturing strategy, future capability development, standards governance, and continuous improvement

Requirements:

  • Bachelor's degree in Engineering, Science, or a relevant technical discipline required
  • Typically 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations, or regulated manufacturing experience
  • 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 in pharmaceutical, biopharmaceutical, medical device, API, peptides, biologics, sterile, or similarly regulated manufacturing environments preferred
  • 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
  • Knowledge of biologics sterile fill-finish systems
  • Knowledge of EU GMP Annex 1 contamination control strategy, aseptic processing, and sterility assurance
  • Knowledge of equipment/facility interfaces and strategic capital investment leadership
  • Experience with engineering governance, standards, technical risk management, project execution, vendor coordination, GMP, isolator/RABS design, Grade A critical zones, background classification, aseptic intervention strategy, operational readiness, and handover support

Benefits:

  • Paid time off including vacation, holidays, and sick leave
  • Medical, dental, and vision insurance
  • 401(k)
  • Long-term incentive programs
  • Travel opportunity (20% of the time)
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