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Overview
The Associate Director, Manufacturing Technology and Support (MTS) is responsible for providing leadership and engineering resources within Manufacturing Operations. They must be able to apply broad knowledge and expertise in the areas of biopharmaceutical manufacturing, equipment validation, cleaning validation, and Lean Six Sigma. This position provides tactical and strategic direction to the MTS team and promotes the behaviors and principles that drive continuous improvement throughout the organization. They ensure that objectives are achieved at the lowest cost consistent with Fujifilm, Regulatory Agency and State and Local code requirements for quality, EEO, employee and environmental safety and health.
External US
MAJOR ACTIVITIES AND RESPONSIBILITIES:
• Provide leadership, direction and manages a diverse group of engineers responsible for production improvements, equipment qualification and validation, cleaning qualification and validation, manufacturing training, and problem solving analysis
• Prepare departmental budget, and track spending and project deliverables against budget and project timelines
• Work with functional leadership to ensure that the MTS group is adequately staffed, roles and responsibilities are defined, and projects are executed to timeline and budget
• Provide leadership, direction and resources to support production activities including the execution of clinical and commercial production processes
• Provide support and direction to the MTS team to improve manufacturing effectiveness, including the cost to manufacture
• Provide resources to maintain equipment in a validated state. Review and approve validation protocols and final reports, ensuring compliance with validation standard operating procedures, policies, cGMPs, and industry standards
• Communicate equipment and operational constraints in relation to proposed timelines and in relation to existing projects
• Interact professionally with customers, vendors and partners to effectively communicate operational issues, schedules, and status relevant to meeting project commitments
• Develop staff skill levels, manage department skill gaps and actively seek to close those gaps
• Adhere to all safety requirements and follow safe procedures, immediately notifying management or Safety when unsafe conditions or potential hazards are found; attend all required safety and health training, including handling hazardous waste, when necessary
• Actively participate and show commitment to collaboration and sharing of best practices with internal/external SMEs and customers
BACKGROUND REQUIREMENTS:
• BS in Engineering, Science, or another technical field is preferred but not required
• 10+ years’ experience in more than one functional area, such as Manufacturing Operations, Quality Operations, Technical Operations, Manufacturing Technical Support, Engineering (Central, Chemical, Industrial, and/or Process), Production Planning and New Products Planning
• Concurrently, minimum of 5 years operations line positions, with responsibility for direct and indirect reports
• Demonstrated knowledge of Operational Excellence tools and methodology preferred
• Proficiency required in the following competencies; Empowering leadership including staff development, flexibility, communication and a commitment to continuous improvement and Lean Six Sigma
• Willing to work irregular and/or rotating shifts
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
