Sr. Engineer - Manufacturing Equipment & Systems

Flexible & Integrated Technical Services, LLC•Juncos, PR

About The Position

FITS is seeking a Senior Engineer to provide validation services in the Engineering area and support a leading biotechnology manufacturer. The role serves as the technical owner for critical manufacturing equipment, assessing failures, driving corrective actions, and leading improvements to maintain reliable, compliant systems. The position involves complex engineering assignments, developing and improving techniques and procedures, and applying mature engineering knowledge to plan and conduct projects. The schedule is administrative and may vary according to business needs.

Requirements

Bachelor’s degree.
Four years of experience as an Engineer in the pharmaceutical or regulated industry.
Project management skills.
Bilingual in English and Spanish.

Nice To Haves

Manufacturing equipment support in a regulated pharmaceutical or biotechnology environment.
Experience as a System Owner and conducting engineering impact assessments.
Technical investigations, failure analysis, and CAPA experience.
IBM Maximo work order management experience.
Experience with preventive maintenance strategies, Job Plans, and SOPs.
Experience with engineering controls for safety incidents.
Equipment troubleshooting, obsolescence, and modernization project experience.
Experience with biopharmaceutical equipment, including centrifuges, autoclaves, process tanks, chromatography, UF/DF, homogenizers, and filter integrity testers.

Responsibilities

Assess failures involving critical manufacturing equipment and drive corrective actions through closure.
Lead improvements that support reliable and compliant manufacturing systems.
Complete complex or novel assignments requiring the development of new 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 and project basis.
Apply advanced engineering techniques or modify advanced techniques within the area of engineering expertise.
Apply engineering principles and practices outside the discipline area to assignments in related fields.
Determine methodologies in at least one area as a peer-recognized engineering technology specialist.
Plan and conduct projects using mature engineering knowledge.