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Packaging System Engineer

Crystal Equation Corporation
Albany, OH Full Time
POSTED ON 2/13/2025
AVAILABLE BEFORE 5/13/2025

Engineer - System Owner

Onsite

Top 3 Must Have Skill Sets :

  • Project Management
  • Problem Solving & Root Cause Analysis
  • Communication and Teamwork

Red Flags : No engineering degree

  • No experience with packaging equipment
  • Summary :

    In this role the Line Owner / System Owner must work under general supervision, owns all the technical aspects in a manufacturing line. The processes were 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, analyzes 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 fulfill area technical and equipment needs.

    Responsibilities :

  • 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
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