Job Description

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.

The Associate Director of Facilities and Engineering leads 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 be responsible for engineering teams, ensure compliance with regulatory standards, manage complex projects, and enhance 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. This role will be based in Tarzana, CA.

What you will do:

Manage the maintenance and optimization of company facilities, including laboratories, production areas, and administrative spaces.
Perform hands-on repairs 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 improve 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 supervise preventive and predictive maintenance programs to enhance equipment reliability and performance.
Identify 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 the 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 budget.
Collaborate with teams, including R&D, Quality, Manufacturing, and Supply Chain, to ensure an 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 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 enhance 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-centered maintenance programs to improve equipment reliability and performance.
Use root cause analysis and techniques to find and address equipment failures.
Develop and monitor goals to measure the effectiveness of maintenance programs and identify areas for improvement.
Manage hands-on reliability-centered maintenance programs to improve equipment reliability and minimize downtime.
Analyze maintenance data to identify trends and areas for improvement, implementing RCM practices to improve maintenance activities.
Ensure execution of RCM strategies and address any issues or failures promptly.
Prepare and maintain detailed documentation for validation, metrology, engineering, capital projects, and asset management activities.
Create regular reports on project status, maintenance activities, and asset performance, ensuring accuracy and compliance with regulatory requirements.
Ensure all documentation meets internal and external standards.
Ensure all activities follow regulatory requirements, industry standards, and company policies.
Develop safety protocols and emergency response plans, conducting regular safety audits and inspections.
Address' safety issues and ensure compliance with health, safety, and environmental regulations.
Identify process improvements to enhance operational efficiency, reduce costs, and improve system reliability.
Provide leadership, mentorship, and training to the facilities, engineering, validation, and metrology teams.
Champion a culture of continuous improvement, collaboration, and accountability within the department.

Minimum Qualifications:

Bachelor's degree in Engineering, Facilities Management, or a related field
Minimum 10 years of hands-on experience in facilities management, engineering, validation, metrology, capital projects, asset management, and reliability-centered maintenance in a pharmaceutical or regulated industry.
Experience managing complex projects and operations, with technical and practical skills.
Knowledge of GMP, FDA regulations, and other relevant compliance requirements.
Office and on-site facilities environment, with frequent hands-on work in laboratories, production areas, and maintenance sites.
Occasional travel to multiple company sites or off-site locations.
May require occasional evening or weekend work to address urgent issues or project needs.

When we put unexpected teams in the same room, we fuel ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base salary for this position ranges from $132,394 to $198,590. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

04-Nov-2024

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.