Senior Manufacturing Engineer proficient in Filling & Packaging equipment specification, procurement, installation and commissioning in a GMP environment. Ability to manage multiple equipment (new or upgrades) projects through to completion under minimal to no supervision. Understanding of equipment processes in GMP manufacturing environment. Excellent verbal/written communication skills, scheduling tasks/meetings and overall task management of equipment projects are essential pre-requisites for the position. Uses technical/business knowledge and expertise to support Operations in the design, scale-up, optimization, specification, procurement, installation and qualification of filling and packaging processes or equipment. Supports the preparation of any user/system requirements, bid package, capital justification, and factory acceptance/commissioning testing for all new filling and packaging equipment. Defines specifications of diagnostic equipment and packaging components in accordance with manufacturing capabilities and marketing objectives. Applies engineering principles and financial expertise to improve diagnostic manufacturing performance, promote cost reductions and achieve optimum level of quality and efficiency. Ability to manage equipment projects from design concept/user requirements through to installation/qualification, including collaboration with suppliers/vendors. Ability to evaluate filling & packaging processes to identify potential non-conformances stemming from equipment performance or supplier plastic component (e.g. bottle, cap). Collaborate with stakeholders, perform root cause investigations, recommend corrective actions and report on results. Prepares production documents (Packaging Records, Filling Records, Labeling Records) as needed. Investigates and resolves problems related to existing equipment functionality, and determines root cause of issues in conjunction with customer complaints. Bachelor of Science in Engineering. Mechanical Engineering, Packaging Engineering or Industrial Engineering preferred. Minimum 5 years work experience. Experience with GMP manufacturing operations, equipment and equipment suppliers, preferably automated liquid filling and packaging. Strong technical, analytical and problem solving skills required. Strong organizational and time management skills, ability to establish priorities to finish tasks, ability to re-prioritize tasks/projects as needed, ability to multitask, track status/progress and report/present updates as required. Excellent interpersonal skills required to interact with stakeholders, e.g. Filling, Packaging, Quality Assurance, and Procurement. Excellent technical writing skills required. Previous good manufacturing practices (GMP) or background in an FDA-regulated environment in an engineering support role a plus. Proficient skills level with using Microsoft applications, including Word, Excel, Visio and MS Project. Previous experience with suppliers of injection-molded components and plastics processing used in FDA regulated industries. Relocation benefits are not available for this position.
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