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Manufacturing Engineer: Becton Dickinson & Company (BD)

The Manufacturing Engineer provides direct engineering support for processes and equipment used to compound, fill, package, and sterilize pharmaceutical products. He/She will collaborate with multiple site functions to implement new equipment and processes. The incumbent is a key contributing member to the manufacturing team. Responsibilities include active partnership with others to select and manage vendors, design, select, modify, and maintain equipment and processes. He/She will implement peripheral equipment used in the manufacturing/packaging/material conveyance process. Supports the integration of purchased equipment during acceptance, installation, validation, and ongoing manufacturing, along with authoring workplace documentation. The incumbent prepares and analyzes process and equipment layout to optimize staffing efficiency, material flows, and quality improvements. Identifies and implements significant continuous improvement projects on existing processes. Performs individual engineering activities as directed by Manufacturing Manager. May also be indirectly responsible for the performance of direct reports or others in the role of project leader. Provides leadership to enable improved manufacturing technologies; He/She will demonstrate creative problem solving skills. He/She will generate solutions to enable daily manufacturing and packaging of sterile products.

The Manufacturing Engineer will coordinate his/her efforts with plant engineering, process engineering (France team), Logistics, Quality, and Engineering, to develop and implement machines required for cost effective manufacturing. Provides requirements needed in validations and accountability for resulting product quality and process efficiency. The above duties will be carried out within a sterile manufacturing environment leveraging prior experience. He/She will enact 21 CFR part 11 guidance.

• Operates within the manufacturing unit
• Owner of manufacturing process equipment, ensures proper maintenance, performance, and continuous improvement planning of all processes in manufacturing
• Manufacturing equipment to include from compounding suite through filling, material handling, inspection, packaging, and pallet packing
• Identifies and requests engineering support to drive and enhance productivity of equipment existing and provides input into new equipment
• Leads manufacturing technical resources to properly maintain equipment, ensures PM performance to plan, monitors and adjusts maintenance to support equipment and process productivity
• Participates within the manufacturing unit to identify and drive unit performance goals and objectives
• Identifies annual budgeted spending within manufacturing unit for equipment modifications and upkeep
• Identifies resource needs from other plant functional areas
• Helps lead technical staff training needs
• Assists to troubleshoot and perform equipment tear down and repair as needed
• Knowledgeable in automation functioning of equipment
• Leads technical documentation requirements for process changes, and assists with SOP generation and modification
• Assists during tech transfer of new products into manufacturing unit

Required Skills and Knowledge - Bachelor's degree in related field; science, engineering, or manufacturing technology. Minimum 5 years pharmaceutical manufacturing experience. Experience with high performance teams and development of manufacturing, engineering, or regulatory staffs is desirable. Leadership, having provided leadership to exempt and non-exempt employees. Strong interpersonal and project management skills; must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately. Demonstrated business acumen with a proven track record of best practice implementation and accomplishments involving quality, manufacturing, engineering, and warehousing. Ability to work both independently and in partnership with others, proven ability to use initiative and drive to achieve results. Strong conflict resolution skills. Expertise in Microsoft Office applications, including Word and Excel, and data entry experience a plus. Must be willing to travel both domestically and internationally. Must be able to work multiple shifts as needed to meet deadlines

Technical Area of Expertise - recognized expertise in regulatory requirements, equipment engineering, and aseptic technique required
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