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
