Position Summary:
The Project Engineer (Finishing/Filling) is responsible for ensuring new and existing projects involving syringe, IV Bag, and vial equipment (labeling/inspection/packaging/filling) are executed appropriately within the team and expected designed timelines. The Project Engineer will ensure timelines are met, budgets are maintained, and action items are completed for projects. The Project Engineer applies project management practices and processes to various projects. The Project Engineer will work directly with the Engineering team, Operations, Maintenance, and Manger of Project Management.
Job Responsibilities:
- Manage all business aspects of the project; timelines, project updates and budgetary considerations
- Monitor change of scope management and tracking
- Manage an appropriate number of active projects, ensuring all assigned projects are delivered on time managing the revenue and the budget
- Lead the team to resolve all project issues and resource constraints affecting the project
- Manage complex projects from pre-formulation onwards independently
- Deliver feedback to functional leadership on project team member performance
- Facilitate positive team member interaction and manage conflict
- Participate in project management improvement initiatives
- Present to senior staff and executive leadership, as required
- Perform other duties as assigned
Required Skills:
- General pharmaceutical knowledge of aseptic manufacturing processes and packaging equipment, unit operations, process control systems, computer systems, equipment cleaning, sterility assurance, process, hazards, and safety is a plus
- Ability to work with others, understanding requirements of material receipt, manufacture, test and release as well as CGMP requirements for commercial production
- Advanced computer skills with spreadsheets, word processing, and databases
- Knowledge of Microsoft Project or similar project scheduling (Required)
- Root Cause Analysis methodology, FMEA, Microsoft Visio, AutoCAD, Minitab, Jump, or similar statistical software. (Preferred)
- Ability to be a team player
- Self-motivated
- Highly organized
Education and Experience Requirements:
- PMP Certification (Preferred)
- B.S./M.S. Degree in Engineering, or Relevant Field, Required
- 5-10+ years pharmaceutical industry experience, required (or similar relevant industry)
- 8+ years' experience managing capital projects
- Brownfield /Greenfield Site Experience is a plus
- Must understand the entire development process through engineering program and project management, conceptual design, detailed design, prototyping, manufacturing, performance analysis, and technical documentation.
- Solid understanding of pharmaceutical or similar finishing/filling line equipment, mechanically and operationally, is required
EOE, including disability/vets.
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