Engineer Senior #JN -052021-64543

Louisville, Kentucky
Industry: Mechanical / Manufacture / Electrical Engineers
Job Number: JN -052021-64543

Description:

  • In this vital role you will serve as the site System Owner for the Secondary Packaging Area Equipment and Business Systems (e.g. Systech Guardian and Manufacturing Execution System). Under general supervision you will also apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.

 Responsibilities:

  • Work cross-functionally with individuals and project teams in Operations, Facilities & Engineering (F&E), Validations, and Quality Unit
  • Create and execute to project plans and schedules
  • Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related development documents for assigned projects in the Secondary Packaging Area
  • Support Secondary Packaging Area and team-up with F&E to resolve day-to-day equipment issues. Create and execute work orders.
  • Support to commercial secondary packaging production by configuring equipment (e.g. Vision System Inspection Tools), if needed
  • Participate in network meetings for business systems (e.g. Systech Guardian and Manufacturing Execution System)
  • Support periodic validation review for secondary packaging equipment
  • Own periodic validation and accounts review for business systems
  • Own Administration Standard Operating Procedure (SOP) for business systems
  • Own secondary packaging equipment and business systems documentation (e.g. URS, DS, Characterization Protocols)
  • Support to secondary packaging commissioning activities (e.g. IOQ, PQ) including risk assessments
  • Own IS validation deliverables for business systems

 Basic Qualification:

  • BS in Engineering and 3 years of experience in pharmaceutical, medical device or biotechnology company


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