Senior Director Process Engineering

Position Summary

The Sr Director Process Engineering BDS CGT sets enterprise direction and senior technical governance for process engineering strategy, process platform deployment, process package design, technical assurance, manufacturing technology interfaces and project delivery for biologics drug substance and cell and gene therapy manufacturing within AbbVie Strategic Investment.

Key Responsibilities

• Establish, maintain and deploy global engineering standards, technical practices and governance expectations for biologics drug substance and cell and gene therapy process engineering.
• Drive consistent application of technical standards, design principles, lessons learned and engineering playbooks across regions, sites and capital projects.
• Define enterprise standards, engineering requirements and technical guardrails for new biologics drug substance and cell and gene therapy technologies.
• Provide governance and escalation for technical decisions with material safety, quality, compliance, cost, schedule, operability or lifecycle impact.
• Provide engineering leadership for strategic capital investments, including new facility builds, technology platform deployments and lifecycle technology upgrades.
• Support front-end engineering, facility concept development, investment option evaluation and manufacturing capability assessments.
• Lead or support technical decision-making across multiple manufacturing sites, capital projects and technology platforms.
• Coordinate technical input from project teams, site SMEs, external engineering partners, vendors and cross-functional stakeholders.
• Partner with manufacturing operations, quality, validation / CQV, EHS, site engineering, MS&T, supply chain and finance.
• 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.
• Lead, coach and develop a high-performing technical engineering team with clear priorities, accountability and development plans.

Qualifications

• Bachelor's degree in Engineering, Science or a relevant technical discipline required; advanced degree preferred where relevant.
• Typically 15+ years of relevant engineering, manufacturing, capital project, technical operations or regulated manufacturing experience.
• Demonstrated technical capability in biologics drug substance and cell and gene therapy process engineering strategy, process platform deployment, process package design, technical assurance, manufacturing technology interfaces and project delivery.
• Experience supporting biologics drug substance, cell therapy, gene therapy, viral vector, mRNA, sterile biologics or similarly regulated biopharmaceutical manufacturing environments preferred.
• Demonstrated ability to work across global functions, manufacturing sites, project teams, suppliers, vendors and external engineering partners.
• Strong communication, risk management, technical judgment, stakeholder engagement and structured problem-solving skills.

Technical Competencies

• Biologics drug substance and cell and gene therapy process design and process package review
• Front-end engineering and concept development
• Biologics and CGT technology transfer, platform deployment and manufacturing scale-up
• Process safety and CQV interfaces
• Strategic capital investment and new biologics / CGT technology deployment support
• Engineering governance and standards
• Technical understanding of bioreactor, harvest, purification, single-use, closed processing, aseptic processing, viral vector, cell processing and cryogenic / cold-chain interfaces
• Technical risk management
• Project execution support
• Stakeholder management
• Vendor / partner technical coordination
• GMP and regulated manufacturing awareness
• Operational readiness and handover support