Equipment Engineer

1 week ago

New Albany, United States Infotree Global Solutions Full time

Description:

  • In this role the Line Owner/System Owner must work under general supervision, owns all the technical aspects in a manufacturing line. The processes where the SO/LO Engineer shall be familiar with are: characterization of process optimization strategies and/or solving problems of operational issues in the packaging operations, manufacturing, pilot technologies or capital projects.
  • Applies basic engineering principles to the design and implementation of system modifications, experiments, and/or capital projects. Organizes, analyses, and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.
  • As a technical resource of an area, System owner / Line Owner Engineer shall interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. At the same time, the System Owner/Line Owner Engineer shall be able to define designs requirement to the service providers to fulfil area technical and equipment needs.

Specific responsibilities include but are not limited to:

  • Provide solutions to a variety of technical problems of moderate scope and complexity.
  • Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
  • Initiate and complete routine technical tasks.

Operations Engineering:

  • Function as a technical specialist to equipment or systems regarding problem solving operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
  • Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of complexity.
  • Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.

Design Engineering:

  • Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
  • Work with consultants, architects, and engineering firms on development of standard design documents.
  • Acquire and critique quotes for equipment modifications or installations.
  • Generate rudimentary project cost estimates and schedules.

Preferred Qualifications:

  • Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
  • Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
  • Knowledge of pharmaceutical/biotech processes
  • Familiarity with validation processes for Packaging areas
  • Familiarity with serialization process and networking
  • Familiarity with documentation in a highly regulated environment
  • Ability to operate specialized equipment, tools, and computers as appropriate.
  • Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
  • Ability to apply engineering science to production.
  • Able to develop solutions to routine technical problems of limited scope
  • Comprehensive understanding of protocol requirements.
  • Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
  • Excellent communication (verbal/written) and presentation skills
  • Demonstrated interpersonal skills including collaboration, influencing, and facilitation
  • Protocol and script testing Writing
  • Dealing with and handling change
  • Packaging Equipment Technical knowledge
  • Analytical Problem Solving
  • Comprehensive understanding of validation protocol implementation requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
  • Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context


Top 3 Must Have Skill Sets:

  • Project Management
  • Problem Solving & Root Cause Analysis
  • Communication and Team Work


Day to Day Responsibilities:

  • Work with operations to ensure equipment is operating correctly.
  • Work with maintenance on equipment breakdowns.
  • Write / Update documents related to equipment and maintenance.
  • Attend meetings
  • Improve equipment performance through continuous improvement projects.
  • Lead small projects for packaging line improvements

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