Sr. Engineer

Flexible & Integrated Technical Services, LLC•Juncos, PR

1d•Onsite

About The Position

This role is for a Sr. Engineer within the Quality Services area of the Engineering department. The position requires a Bachelor's Degree with four years of experience as an Engineer in the pharmaceutical or regulated industry. Key responsibilities include managing projects, technical writing, and applying engineering principles to solve complex problems. The ideal candidate will possess strong technical skills, bilingual abilities (English & Spanish), and a proactive, ethical, and scientific approach to problem-solving within a team-oriented environment.

Requirements

Bachelor's Degree with four (4) years of experience as an Engineer within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills.
Experience in Change Control, nonconformance, corrective and preventative actions, and validation practices.
Experience in Technical Writing and cGMP procedures and engineering.
Experience with Maximo and Purchase Orders (PO).

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.
Apply 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.