Summary: Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant, or capital projects environment.
Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, and process and/or capital projects.
Develops, organizes, analyzes, and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
Functions: Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
Develop engineering policies and procedures that affect multiple organizational units.
Supervise, coordinate, and review work of a small staff of engineers, associates, and/or technicians on an ongoing basis as well as on a project basis.
Employ advanced engineering techniques and/or modifications of advanced techniques within the area of engineering expertise.
Apply knowledge of engineering principles and practices outside of the area of discipline expertise to a broad variety of assignments in related fields.
Serve as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Apply mature engineering knowledge in planning and conducting projects.
Other functions may be assigned.
Design Engineering: Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Work with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
Work with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
Coordinate the work of consultants, architects, and engineering firms on the development of standard design documents.
Develop departmental budgets or project budgets encompassing multiple disciplines for the area within a project or the entirety of smaller projects.
Requirements Qualifications: Doctorate degree or Master's degree and 3 years of Engineering experience OR Bachelor's degree in Engineering and 5 years of Engineering experience.
Preferred Qualifications: Working knowledge of pharmaceutical/biotech processes.
Familiarity with validation processes and documentation in a highly regulated environment.
Ability to operate specialized laboratory equipment and computers as appropriate.
Demonstrated skills in problem-solving, applied engineering, basic technical report writing, and verbal communication.
Comprehensive understanding of validation protocol execution requirements.
Skills in basic technical presentations, personal organization, validation protocol writing, managing change, technical (equipment specific), analytical problem solving, and computer literacy.