Associate Director, Facilities and Engineering

At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Position Summary

The Associate Director – Facilities and Engineering manages the engineering functions across facilities maintenance, validation processes, metrology programs, Asset Management, and Reliability-Centered Maintenance and Capital Projects within a pharmaceutical organization. You will oversee engineering teams, ensuring compliance with regulatory standards, managing complex projects, and enhancing operational efficiency through strategic plans, operational efficiency, and facility and equipment performance. At the same time, we are looking for a hands-on approach to project execution, with a focus on maintaining GMP (Good Manufacturing Practices) standards. You will report to the Senior Director of Facilities and Engineering.

Responsibilities

• Manage the maintenance and optimization of company facilities, including laboratories, production areas, and administrative spaces.
• Perform hands-on troubleshooting and repair of facility systems and equipment, ensuring compliance with health, safety, and environmental regulations.
• Oversee the daily operations of the facilities and engineering teams to ensure the efficient functioning of all building systems, including HVAC, electrical, plumbing, and utilities.
• Develop and implement preventive and predictive maintenance programs to maximize equipment uptime and reliability.
• Oversee routine and emergency maintenance activities, coordinating with our teams and external contractors.
• Provide hands-on technical support for engineering projects, including design, installation, and commissioning of systems and equipment.
• Implement and monitor preventive and predictive maintenance programs to enhance equipment reliability and performance.
• Troubleshoot and resolve engineering issues, ensuring systems operate and meet operational requirements.
• Lead validation activities for all equipment and processes, ensuring compliance with FDA and other regulatory requirements.
• Oversee and participate in hands-on validation activities for systems, equipment, and processes to ensure compliance with regulatory requirements (e.g., FDA, EMA).
• Review validation protocols and documentation, addressing any deviations or issues that arise.
• Coordinate with teams to ensure accurate validation outcomes.
• Develop validation master plans, protocols, and reports, and ensure execution of validation activities.
• Oversee the calibration and maintenance of all critical instruments and equipment, ensuring accuracy and compliance with industry standards.
• Manage hands-on metrology programs to ensure accuracy and reliability of measurement systems and instruments.
• Perform calibration and repair of measurement systems, ensuring compliance with industry standards and regulatory requirements.
• Conduct regular inspections and adjustments to maintain metrology standards.
• Lead capital projects, including facility upgrades, expansions, and new installations.
• Plan and implement capital projects from conception through completion, ensuring projects are delivered on time, within scope, and within budget.
• Collaborate with teams, including R&D, Quality, Manufacturing, and Supply Chain, to ensure understanding of project goals and timelines.
• Provide hands-on support in project planning, execution, and management, including installation, testing, and commissioning of new systems.
• Develop project documentation, budgets, and schedules, ensuring projects are completed on time, within budget, and to quality standards.
• Manage capital budgets, providing regular updates to senior management.
• Manage facility upgrades, renovations, and expansions to meet evolving our needs.
• Ensure compliance with all local, state, and federal regulations, including GMP and EHS (Environmental, Health, and Safety) standards.
• Develop and implement asset management strategies to maximize the value and lifespan of company assets.
• Perform hands-on tracking, maintenance, and optimization of assets, supporting the implementation of asset management processes.
• Analyze asset performance data and provide recommendations for improvements and corrective actions.
• Implement and lead reliability-cente