Sr Engineer

BioPharma Consulting JAD Group

  • Juncos, PR
  • Autónomo
  • Tiempo completo
  • Hace 20 días
Job Description:The successful candidate will independently provide and direct the characterization of process optimization strategies and troubleshoot operational issues in the operations, manufacturing, pilot plant, or capital projects environment. They will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process, and capital projects. They will develop, organize, analyze, and present the interpretation of results for operational issues or engineering projects of significant scope and complexity.Functions: * Complete complex or novel assignments requiring the development of new and/or improved engineering techniques and procedures.
  • Develop engineering policies and procedures that affect multiple organizational units.
  • Supervise, coordinate, and review the 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.
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 the project or entirety of smaller projects.
Preferred Qualifications:
  • Working knowledge of pharmaceutical/biotech processes.
  • Familiarity with validation processes.
  • Familiarity with documentation in a highly regulated environment.
  • Ability to operate specialized laboratory equipment and computers as appropriate.
  • Ability to interpret and apply GLPs and GMPs.
  • Ability to apply engineering science to production.
  • Able to develop solutions to routine technical problems of limited scope.
  • Demonstrated skills in problem-solving and applied engineering, basic technical report writing, and verbal communication.
  • Comprehensive understanding of validation protocol execution requirements.
  • Demonstrated skills in basic technical presentations, personal organization, validation protocol writing, dealing with and managing change, technical (equipment specific), and analytical problem-solving.
  • Specialized equipment/process expertise.
  • In-depth knowledge of validation processes and requirements as applied to new equipment installations.
  • Interacts effectively with a variety of communication and working styles.
  • Ability to independently determine when additional internal resources are required to solve problems.
  • Ability to handle multiple projects at one time.
  • Demonstrated skills in schedule development, facilitation, collaboration, basic project management, completion, and follow-up.
  • Established expertise in at least 3 separate areas of engineering technology.
  • Ability to independently determine when additional external resources are required to solve problems.
  • Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
  • Problem-solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
  • Working knowledge of financial analysis tools.
  • Ability to delegate and manage the project work of others.
  • Demonstrated skills in negotiation, persuasion, facilitation, collaboration, project cost development, conflict resolution, leadership, and team building.
  • Management of contractors and vendors.
Requirements:Education:
  • Bachelor's degree in Engineering and 5 years of Engineering experience or
  • Master's degree and 3 years of Engineering experience or
  • Doctorate degree
  • Shift: 8hrs | 2ND and 3rd shifts

BioPharma Consulting JAD Group

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