- Bachelor's Degree
- Associate's Degree
- FDA Regulations
Job Description Summary
This position is responsible for delivering projects to the manufacturing operation. This individual will develop and implement improved methods of manufacturing, procedures, and processes that result in improved efficiencies, yields, machine operations, and quality. This individual will provide technical support and training to the development group and manufacturing operations for the implementation of new products or processes.
PRIMARY JOB RESPONSIBILITIES
Project Planning and Execution – Prepares and implements project or improvement plans for areas of responsibility including but not limited to: efficiency improvements, cost reduction or quality improvement programs, line installations, new product support and other process improvements. The plan or proposal is to include the proposed technical approach, estimated implementation costs, estimated resource needs, and a time schedule (Gantt chart). Acts as the driving force for the project, coordinating all resources and activities necessary to ensure on time execution to the project or process improvement plan, identify and work through barriers that hinder progress.
Technical Writing / Documentation – Must possess excellent technical writing ability. Required to prepare process job descriptions and manufacturing specifications, thoroughly documents all equipment, machines, and tooling with accurate and clear detailed prints and maintenance instructions.
Validation – With the assistance of the Quality Engineer and validation team, creates all necessary documentation associated with the BD change control process and coordinates validation activities to ensure on time execution according to the project or process improvement plan.
Manufacturing Support – Provides technical guidance as needed to manufacturing and hourly technical personnel during the startup of new or changed products and processes. Expected to use good decision making, problem solving and trouble-shooting techniques to minimize the potential of/or to correct ongoing manufacturing issues.
Capital Request / Capital Management – Prepares a plan for procurement of capital equipment including obtaining of quotes, vendor investigation, budgeting, and scheduling. Prepares specifications, place orders, coordinate procurement, install equipment, debug and coordinate the startup of new or modified equipment from outside firms or as modified internally, manages capital spending on assigned projects to ensure spending in accordance with the plan capital budget.
Design – Coordinate design activity with outside vendors or internal departments as necessary. If resources are unavailable, perform own design and drafting as required. Redesigns or oversees the redesign of existing equipment to incorporate improvements relating to safety, machine reliability, product quality, and / or cost reduction.
Supervision / Leadership – Will indirectly supervise all resources assigned to project teams.
QUALIFICATIONS AND REQUIREMENTS
Bachelors' of Science Degree in Mechanical Engineering or a related engineering discipline from a recognized, accredited university or
Associates' Degree in a related engineering discipline with greater than 4 years of engineering related experience
Demonstrated ability to lead engineering projects related to productivity improvement, cost savings, capacity expansion or new process development
Knowledge of cGMP, FDA regulations and/or medical device manufacturing experience is desired
Works well in a team demonstrating an ability to communicate laterally and vertically in an organization.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status. #LI-OPS
Primary Work Location
USA NE - Columbus (West)