Sr Engineer

Flexible & Integrated Technical Services, LLCJuncos, PR
Onsite

About The Position

This role is for a Sr Engineer within the Validation services area of the Engineering department. The ideal candidate will have a Bachelor's Degree with four years of experience as an Engineer in the pharmaceutical or regulated industry. Bilingual (English & Spanish) skills are required, along with Project Management experience. The position operates on an administrative shift but requires availability for non-standard shifts, including nights, weekends, and extended hours, as dictated by project needs. Experience in Packaging Equipment, Design of new equipment process, and Validations is essential. The role involves completing complex assignments, developing engineering policies and procedures, supervising engineering staff, employing advanced engineering techniques, and applying engineering principles across disciplines. The engineer will serve as a specialist in at least one area, determining methodologies, and applying mature engineering knowledge to plan and conduct projects. This includes developing technical solutions to complex problems, collaborating with various departments (research, manufacturing, process development, utilities, facilities, quality assurance, and validation) to define requirements for system modifications, and working with project managers to ensure projects meet schedule, budget, and quality constraints. The role also involves coordinating external consultants and developing departmental or project budgets.

Requirements

  • Bachelor's Degree
  • Four (4) years of experience as an Engineer within the pharmaceutical or regulated industry.
  • Bilingual (English & Spanish).
  • Project Management skills.
  • Experience in Packaging Equipment
  • Experience in Design of new equipment process
  • Experience in Validations

Nice To Haves

  • Be available to support non-standard shifts, including nights, weekends, and extended hours, if required by the project.

Responsibilities

  • 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 wide variety of assignments in related fields.
  • Serve as a peer-recognized engineering technology specialist in at least one area, responsible for determining methodologies in that area.
  • Application of mature engineering knowledge in planning and conducting projects.
  • 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 that encompass multiple disciplines for the area within the project or the entirety of a smaller project.
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