AstraZeneca
US – Tarzana –, CA
Shift: Full time
Introduction to role The Senior Engineer, Automation Controls – Facilities Engineering is responsible for leading and managing the technical aspects of facilities and process automation /controls , including development and validation, engineering projects, and capital investments within a pharmaceutical organization. This role involves providing expert technical guidance, overseeing complex projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency. Accountabilities Leadership and Oversight: Lead technical teams and provide guidance on facilities and process automation /controls , including development and validation activities, engineering solutions, and capital projects. Mentor and support junior engineers and other technical staff in development of cross functional support for automated systems . Collaborate with cross-functional teams to align engineering and project activities with organizational goals. Facilities Management: As asset owner, o versee the maintenance and operation of automat ion /control systems and equipment within the site including critical facilities /utilities , laboratories, production areas, and administrative spaces. Develop and implement strategies for facility automation/ controls improvements and upgrades to enhance operational efficiency and compliance. Ensure automat ion /controls systems adhere to health, safety, and environmental regulations. Validation Management: Lead the development and execution of validation strategies, protocols, and documentation for site systems, equipment, and processes with focus on assets associated with automation/controls . Ensure that validation activities meet regulatory requirements (e.g., FDA, EMA) and internal standards. Manage complex validation projects, including protocol design, execution, and reporting. Automation/ Controls Oversight: Oversee automation/controls programs to ensure the reliability of systems including electrical components, software environments , and automated field devices . Develop and implement maintenance and inspection programs for critical equipment. Ensure automation/controls engineering procedures and processes comply with industry standards and regulatory requirements. Engineering Leadership: Lead engineering projects related to the design, installation, and commissioning of systems and equipment. Ensure engineering activities adhere to Good Manufacturing Practices (GMP) and other relevant regulations. Develop and implement preventive and predictive maintenance programs to enhance equipment reliability. Capital Projects Management: Manage all aspects of capital projects, including automation/ controls systems upgrades, expansions, and new installations . Develop project plans, budgets, and schedules; monitor progress and ensure projects are completed on time and within budget. Coordinate with internal stakeholders, external contractors, and vendors to achieve project objectives and compliance. Documentation and Reporting: Prepare and review comprehensive documentation for qualification/ validation, engineering procedures and work instructions , and capital projects. Generate detailed reports on project status, validation results, project activities, and asset ownership/ maintenance work. Ensure that documentation is accurate , complete, and compliant with regulatory requirements. Compliance and Safety: Ensure all facilities, systems, and processes comply with regulatory requirements and industry standards. Develop and enforce safety protocols and emergency response plans. Conduct regular audits and inspections to ensure compliance and address any issues promptly. Continuous Improvement: Identify and implement process improvements to enhance efficiency, reduce costs, and improve system reliability. Stay current with industry trends, technological advancements, company guidance, and regulatory changes to ensure best practices are applied. Essential Skills/Experience Bachelor’s degree in Engineering , Electrical Engineering preferred , or a related engineering field; Master’s degree preferred. 7-10 years of experience in automation/controls software and equipment systems , with background in qualification/ validation, facilities engineering, and capital projects . S ignificant experience in a pharmaceutical or regulated industry is preferred . Extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements. Proven experience in leading complex automation/ controls processes, asset ownership , engineering projects, and capital investments. Strong project management skills with experience in budgeting, scheduling, and resource allocation. Excellent analytical, problem-solving, and communication skills. Ability to manage multiple priorities and work effectively under pressure. Working Conditions: Office and on-site facilities environment, with occasional travel to various company sites or off-site locations. May require occasional