Head of Automation, Associate Director
PharmaBiotechRegulatory AffairsQuality Assurancegmpemafdacroinformaws
Job description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description The Head of Automation is an engineering leader who establishes a compelling vision for the organization and executes against it using sound engineering methodology and a high-performing team. This role provides leadership to the automation engineering function and is accountable for the implementation of all team activities. The primary focus is to ensure automation engineering goals related to safety, compliance, fulfillment, and financial performance are achieved through the efficient use of resources. How you will contribute Operations & Strategy Develop and implement an innovative and compelling vision and strategy for the Automation Group, including Manufacturing Intelligence and Digitization, to meet site objectives. Drive strategic initiatives to ensure complete and appropriate lifecycle management of automated systems. Liaise between Manufacturing and Facilities clients and external engineering and vendor resources throughout the conceptual design, detailed design, specification, procurement, construction, commissioning, and qualification of automation systems for cGMP production facilities. Engage across Takeda and external networks, including Global Engineering, manufacturing sites, industry forums, and subject matter experts, to drive continuous innovation and solve complex equipment and process issues. Provide in-depth process automation expertise across technologies such as cell culture, purification, filling and packaging, and cell therapy. Support Manufacturing and Operations by providing strategic direction and tactical support, including troubleshooting day-to-day issues and assigning personnel to deliver comprehensive solutions. Monitor automation technology trends and industry benchmarks to ensure the Thousand Oaks site remains aligned with peer organizations. Provide resources and support across the engineering project lifecycle, including conceptual and detailed design, specification, implementation, commissioning, qualification, troubleshooting, and continuous improvement of automation and instrumentation for biopharmaceutical production and supporting utility systems. Assess risk and provide guidance on redundancy requirements for automation systems. Assess, analyze, recommend, and direct improvements that increase productivity, capacity, reliability, and compliance within the Automation Department. Establish, develop, and drive Good Engineering Practices across projects and support services, using established methodologies for project, portfolio, maintenance, and work order management. Facilitate coordination and harmonization across Validation, Manufacturing, Facilities Engineering, Maintenance, Manufacturing Services, R&D, EHS, and Regulatory teams. Serve as the site Automation subject matter expert during internal and external regulatory audits, including interactions with FDA and EMA representatives, and defend current practices as needed. Ensure accountability for all deliverables, including schedule milestones, financial performance, and quality of scope for assigned projects. Manage and forecast capital and expense budgets. Perform other duties as assigned. Leadership Lead and manage a team of automation engineers and represent the automation engineering function to partner groups, including IT, Quality, Validation, Manufacturing, Facilities, Global Engineering, and Global Automation. Ensure high-quality work and appropriate resources are available to support operations, projects, and ongoing initiatives. Coach, motivate, develop, recognize, and mentor engineering staff, including senior-level engineers and managers, while developing future leaders. Provide engineering expertise and direction to employees and contractors to meet project and support schedules and financial goals while ensuring technically successful solutions. Develop and strengthen the core competencies of site automation subject matter experts to build technical capabilities and retain critical knowledge and experience. Coach and direct others in resolving project issues, drawing on demonstrated success solving difficult and complex problems. What you bring to Takeda Education and experience Bachelor's degree in Engineering required, preferably Chemical, Mechanical, or Electrical Engineering. Minimum 12 years of experience in process automation, design, process improvement, and project delivery. Minimum 5 years of leadership experience. Strong communication skills and the ability to communicate effectively with professionals at all levels, both internally and externally. Demonstrated ability to work successfully in a matrixed organization, with excellent interpersonal, influencing, and negotiation skills. Advanced leadership skills with demonstrated success managing and developing teams. Ability to design solutions and influence decisions within and beyond the scope of direct responsibility. Strong problem-solving and troubleshooting capabilities. Strong automation engineering expertise grounded in sound engineering and scientific principles, preferably within biotechnology. Sound industry knowledge, project proficiency, and the ability to operate autonomously; may be recognized as a subject matter expert across relevant disciplines. In-depth pharmaceutical industry knowledge related to process automation system
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