Senior Director Engineering – AML14 Drug Product

Lead an integrated Engineering organization spanning Maintenance & Reliability Engineering, Equipment Engineering, Utilities, Automation, and Inspection Engineering, with oversight of an approximately 150-person organization.

Specific responsibilities include but are not limited to:

• Lead the integrated FF&I Engineering organization and strategy, setting the engineering strategy, operating model, asset roadmap, workforce plan, and technical priorities across Maintenance & Reliability, Equipment Engineering, Utilities, Automation, and Inspection Engineering.
• Deliver manufacturing performance through engineering and reliability excellence, owning the maintenance and reliability system across process equipment, utilities, automation, instrumentation, and supporting assets.
• Improve equipment availability, OEE, changeovers, campaign execution, decontamination reliability, and recovery of lost capacity through preventive, predictive, and optimized maintenance strategies.
• Transform reliability from reactive problem-solving to predictive performance, strengthening the Reliability organization and eliminating repeat failures through rigorous root-cause analysis, sustainable corrective and preventive actions, effectiveness verification, condition monitoring, and early identification of weak signals.
• Establish outcome-based performance management connecting engineering actions to OEE, downtime, lost hours, recovered units, repeat events, MTBF, maintenance effectiveness, and risks to the manufacturing plan.
• Shape the future of FF&I's assets, technology, and infrastructure, owning lifecycle and obsolescence strategies for critical assets, including replacement planning, critical spares, capacity, technology upgrades, utilities, and business continuity.
• Partner on capital investments, facility modernization, new filling and inspection technologies, automation upgrades, and technical improvements, ensuring new capabilities are qualified, operationally ready, and introduced without compromising commercial supply.
• Ensure technical readiness, compliance, and risk management, maintaining the highest standards of safety, quality, cGMP compliance, environmental requirements, and inspection readiness.
• Ensure equipment and technical systems are prepared for product launches, technology transfers, engineering runs, qualification campaigns, PPQs, and commercial implementation while driving timely and sustainable resolution of quality events, technical deviations, and operational risks.
• Build and lead a high-performing Engineering organization, providing active leadership to an approximately 150-person organization operating through a blended FTE/EW workforce model.
• Build capability through strategic workforce planning, talent selection, development, coaching, functional rotations, performance management, and succession planning.
• Develop leaders who make timely decisions, anticipate and escalate risks, execute independently, and remain accountable for business outcomes rather than activity completion.
• Accelerate digital, AI, and operational transformation, advancing simplification, automation, real-time performance visibility, predictive technologies, advanced analytics, Lean practices, and human-error reduction.
• Build AI literacy across Engineering and establish the responsible use of approved AI capabilities to support predictive-failure modeling, troubleshooting, process-variability trending, planned interventions, and automated analysis.
• Operate as a strategic business leader and enterprise partner, managing the applicable Engineering labor budget, together with applicable maintenance, repair, spare-parts, operating-supply, non-capital equipment, and engineering-technology investments.
• Allocate resources based on supply priorities, risk, asset condition, and business value, while partnering across Manufacturing, Quality, Process Development, Validation, Supply Chain, Digital, enterprise networks, regulatory agencies, suppliers, and external technical partners.

Basic qualifications:

• Doctorate degree in Engineering and 5 years of engineering or manufacturing support experience OR Master's degree in Engineering and 9 years of engineering or manufacturing support experience OR Bachelor's degree in Engineering and 11 years of engineering or manufacturing support experience
• At least 5 years of people-management and/or leadership experience leading teams, projects, or programs, or directing the allocation of resources

Preferred qualifications:

• Significant Engineering, Maintenance, Reliability, Automation, and/or Manufacturing leadership experience within complex, highly regulated manufacturing operations, ideally including aseptic Drug Product filling and inspection.
• Demonstrated success leading large, multidisciplinary technical organizations and developing leaders, technical capability, organizational performance, and succession pipelines.
• Deep understanding of equipment reliability and asset-management strategies, including preventive and predictive maintenance, root-cause analysis, lifecycle management, obsolescence, critical spares, and continuous improvement.
• Experience improving manufacturing performance through OEE, equipment availability, downtime reduction, changeover optimization, capacity recovery, and other measurable operational outcomes.
• 15+ years of progressively complex / strategic cGMP-regulated manufacturing experience, with strong background in filling, formulation, and inspection areas, including support for regulatory inspections and management of technical and quality risks.
• Experience developing and executing engineering strategies, asset roadmaps, capital investments, capacity plans, and technology modernization initiatives while protecting ongoing commercial operations.
• Demonstrated ability to lead complex product introductions, technology transfers, qualification/PPQ activities, capital projects, or manufacturing technology implementations through cross-functional organizations.
• Strong business and financial acumen, including experience managing significant budgets, allocating resources, evaluating competing investments, and connecting engineering priorities to business and supply outcomes.
• Demonstrated ability to use data, advanced analytics, digital technologies, automation, and AI-enabled capabilities to improve engineering decision-making, reliability, productivity, and organizational effectiveness.
• Exceptional leadership, executive communication, influencing, negotiation, and change-management skills, with the ability to make disciplined decisions in ambiguous environments and build strong partnerships across organizational boundaries.
• Ability to create a culture of accountability, safety, quality, transparency, innovation, belonging, and constructive challenge, where teams raise risks early and continuously improve how work is performed.
• Excellent written and verbal communication skills in English; Spanish language proficiency is preferred but not required.