Job Title: Associate Director Operational Technology Automation

Location: Shepherdsville, KY

Introduction to role:

The Associate Director Operational Technology Automation is responsible for maintaining the computer systems supporting both facilities and operational activities at Louisville Distribution Center (LVDC). In this capacity, the OT Automation Associate Director is responsible for site Computerized System Validation, qualification performance, and document maintenance to meet cGMP/GDP compliance as well as supporting IT technical investigations. The OT Automation Associate Director works closely with 3rd party suppliers, LVDC Operations, Quality, Regional and Global OPS IT and Facilities Team members to ensure AZ standards are optimally met.

Accountabilities:

• Primary IT liaison between LVDC Operations, Quality, and Facility Departments.
• Serve as site IT administrator for all locally owned site computerized automation systems by maintaining domain access control, regular administration of locally owned virtual computers, point of contact for offline servers, and perform special requests by Operation, Quality and Facility Departments.
• Owner of the site Computerized System Validation Master Plan.
• Lead validation projects and periodic reviews as the need arises.
• Maintain local Process Control Network uptime/performance and ensure security of locally produced data.
• Responsible for maintenance of site computerized system registry and configuration management database.
• Responsible for communication and identification of risks in the IT system risk registry.
• Responsible for site computerized system validation and technical investigation support.
• Write validation documents related to computerized system validation.
• Write and maintain Validation/Computerized system site specific procedures.
• Support implementation of validated computerized system change requests and resolution of process deviations through technical knowledge, and use of root cause investigation tools, execution of supporting validation studies, and documentation review and approval.
• Work with system validation and system contractors as required.
• Liaise with Regional, Global OPS IT and plan site IT demand accordingly.
• Perform and direct the validation activities including start up protocols, technical reports, specifications, and risk assessments.
• Communicate effectively to management across departments, validation goals, computerized system risks, priorities and policy.
• Ensures site validation SOPs and Master Plans are aligned with Corporate IT policies and standards.

Essential Skills/Experience:

• Bachelor’s degree in science, engineering, or related field
• 5+ years validation experience in pharmaceutical/biological/manufacturing/ or distribution environment
• General knowledge of regulatory requirements, including but not limited to FDA, DEA, DOT, EPA, etc.
• Demonstrated knowledge of computer hardware, software, and operating systems with focus on network support and local area networks
• Proven experience in design, configuration and/or testing of systems
• Knowledge of computerized system validation and strong technical writing abilities
• Proficiency in basic digital literacy required including hands-on working knowledge of MS Word, Excel
• Possess strong analytical skills and overall business acumen knowledge
• Demonstrated strong interpersonal, communication, organizational negotiation, and strategic planning and problem-solving skills

Desirable Skills/Experience:

• Project management
• Supplier management experience
• Extensive knowledge of supply chain principles: GMP, GDP, Regulatory
• Familiar with Lean leadership principles and methods

When we put unexpected teams in the same room, we unleash bold 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.

AstraZeneca offers an environment where you can thrive by working on constant new developments across all stages of drug development. We apply digital and Lean processes to accelerate us forward. Our dynamic environment with complex technical projects encourages innovation while fostering a positive space where ideas are welcomed. We are united behind a common goal to succeed in delivering life-changing medicines to patients.

Ready to make a big impact? Apply now!

Date Posted

12-Mar-2025

Closing Date

27-Mar-2025Our 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.