Director Engineering

Quick Facts

• Role: Director, Engineering
• Focus areas: Engineering, Automation, Maintenance, Instrumentation
• Goal: Safe, compliant, reliable, and efficient drug-substance manufacturing operations

Description

As Director, Engineering, you lead the site’s Engineering, Automation, Maintenance, and Instrumentation capabilities to deliver safe, compliant, reliable, and efficient drug-substance manufacturing operations. You establish and execute long-term technical and organizational strategy to sustain, improve, and expand a complex GMP manufacturing operation while balancing safety, GMP compliance, asset reliability, supply continuity, cost, and long-term capability.

Responsibilities

• Provide strategic and operational leadership for Engineering, Automation, Maintenance, and Instrumentation functions
• Ensure safe, reliable, and compliant performance of manufacturing equipment, automation systems, and instrumentation
• Establish and execute site asset-management strategy, including preventive maintenance, predictive maintenance, calibration, reliability, spare-parts, and lifecycle-management programs
• Lead the engineering compliance program, maintaining inspection readiness and ensuring adherence to cGMP, EHS, quality-system, and applicable regulatory requirements
• Partner with Site Operations, Quality, Digital/Automation, Supply Chain, and Capital Project Delivery to integrate new assets and resolve technical risks
• Lead technical support for installed systems and equipment: system ownership, troubleshooting, root-cause analysis, reliability improvement, and sustainable corrective actions
• Establish governance for maintenance execution and work management (planning, scheduling, backlog management, work-order quality, contractor oversight, performance metrics)
• Develop, manage, and forecast departmental operating and capital budgets; prioritize resources against safety, quality, supply, reliability, and lifecycle risks
• Build and lead a high-performing organization using employees, contingent workers, and service providers
• Set clear accountabilities, develop talent, coach leaders, and create succession plans for critical technical roles
• Manage strategic service-provider relationships; ensure contractors perform work safely, compliantly, and to required quality standards
• Escalate significant quality, compliance, supply, safety, and asset-reliability risks to site leadership with clear options and recommendations
• Drive continuous improvement using data-based decision making, lean maintenance practices, digital tools, reliability engineering, and sustainability initiatives
• Represent the site within global engineering/automation/maintenance/instrumentation networks and adopt leading practices
• Make timely, risk-based decisions and trade-offs to protect patients, employees, compliance, and supply

Requirements

Basic Qualifications

• Doctorate Degree and 4 years of Engineering experience OR Master’s Degree and 8 years of Engineering experience OR Bachelor’s Degree and 10 years of Engineering experience
• At least 4 years of direct people management experience and/or leadership experience leading teams, projects, programs, or directing allocation of resources (may run concurrently with technical experience)

Preferred Qualifications

• 12+ years progressive engineering, maintenance, automation, instrumentation, utilities, reliability, or asset-management experience in pharmaceutical/biotechnology or similarly regulated manufacturing
• 7+ years leadership experience including direct management of technical professionals and accountability for multi-function teams, contractors, and service providers
• Proven experience leading a site-level Engineering, Automation, Maintenance, and Instrumentation organization supporting GMP manufacturing
• Accountability for manufacturing equipment, automation platforms, process instrumentation, clean utilities, and critical production-support systems with measurable results in reliability, compliance, and operational performance
• Experience leading maintenance, calibration, reliability, asset lifecycle, and spare-parts programs in a CMMS such as Maximo
• Demonstrated success building technical organizations (workforce strategy, capability development, succession planning, contractor models, vendor governance)
• Strong track record leading through regulatory inspections, deviations, root-cause investigations, and CAPA implementation
• Experience partnering with capital-project teams through design, commissioning, qualification, turnover, and operational readiness
• Ownership of substantial operating and capital budgets, resource plans, cost forecasts, and business cases
• Ability to set technical strategy, make risk-based trade-offs, and escalate key risks (safety, quality, compliance, supply, asset reliability)
• Experience implementing engineering excellence, reliability, digital, sustainability, energy-efficiency, or continuous-improvement initiatives at site scale
• Strong executive communication skills and influence across Operations, Quality, Supply Chain, EHS, Digital/Automation, and global technical networks
• Proficiency with Microsoft Office and enterprise systems such as Maximo (or equivalent CMMS platforms)

Benefits

• Total Rewards Plan including health and welfare plans for staff and eligible dependents
• Financial plans with opportunities to save toward retirement or other goals and work/life balance
• Retirement and Savings Plan with generous company contributions
• Group medical, dental, and vision coverage
• Life and disability insurance and flexible spending accounts
• Discretionary annual bonus program (or sales-based incentive plan for field sales representatives)
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements where possible
• Career development opportunities