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Director, Engineering (GMP Facilities)

Employer
Automatic Data Processing, Inc.Orporated
Location
Baltimore, MD
Closing date
Jun 20, 2019

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Company in the Research sector. Provide leadership in the global Process and Automation strategy and portfolio management. Direct internal and external engineering resources toward practical technical developments such as automation of product assembly and implementation of associated manufacturing support systems. Develop a robust and credo-based talent development and succession planning in alignment with functional growth strategies. Identify, source, and evaluate new technology applications to support capable and site-appropriate automated manufacturing processes for global applications. Formulate operational requirement specifications in collaboration with cross-functional teams across multiple sites. Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams. Ensure teams select, scale-up, and implement robust manufacturing processes to budget and schedule while maintaining compliance to comprehensive medical device standards. Ensure the use of design for manufacturing, mistake proofing, and quality controls to minimize patient and regulatory compliance risks. Prepare presentation materials to facilitate strategic decision making and approval of multi-site new technology portfolio strategies with Upper Management. Anticipates financial needs, quantifies budget to support project planning, and manages budget per forecast and schedules. Establish and apply a design and change review process to ensure robust manufacturing equipment design, validation, and timely implementation for new and existing processes. Bachelor's degree in Engineering is required; Master's Degree in Engineering, Engineering Management, Technology and/or Business Administration preferred. Minimum of 12 years of experience in designing and implementing automated equipment and processes, as well as significant experience in managing associated technical engineering functions is required. Extensive experience in hands on implementation and support of automation systems within a highly regulated cleanroom manufacturing environment is required. Extensive experience in compliance Regulations that apply to Quality, Regulatory Compliance (21 CFR Part 11), Environmental Health and Safety, as well as have knowledge of standards related to equipment design and implementation into global medical device manufacturing plants.

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