Manufacturing Engineer (2nd Shift)

Flexible & Integrated Technical Services, LLC•Dorado, PR

1d•Onsite

About The Position

We are seeking a Manufacturing Engineer for our Engineering area, specifically for the 2nd shift. This role is crucial for supporting manufacturing services and ensuring the smooth operation of our processes. The ideal candidate will have a strong technical background in engineering and experience in a manufacturing environment, with a focus on validation and compliance.

Requirements

Bachelor's Degree in Mechanical, Electrical, Industrial, Manufacturing, or Biomedical Engineering, or a related technical field.
2–3 + years of experience in a manufacturing environment.
Experience in the generation and execution of validation protocols for manufacturing equipment.
Bilingual (English & Spanish).

Nice To Haves

Experience in qualification, validation, and lifecycle management of manufacturing systems and equipment.
Experience in GMP documentation development, including protocols, reports, risk assessments, deviations, and CAPAs.
Experience in manufacturing process support, troubleshooting, compliance, and continuous improvement initiatives.

Responsibilities

Support the creation, execution, and maintenance of qualification and validation activities related to manufacturing processes and systems.
Generate and maintain manufacturing and system documentation required to support process changes, equipment implementation, and compliance requirements.
Actively support the execution of validation and qualification protocols and generate supporting reports.
Provide ongoing support for daily manufacturing operations and process performance monitoring.
Support activities related to quality system processes and manufacturing compliance requirements.
Monitor manufacturing metrics and assist in identifying opportunities for improvement.
Coordinate qualification, validation, and protocol execution activities across Manufacturing, Quality, and Engineering teams.
Prepare, review, and maintain qualification protocols, validation reports, risk assessments, and other compliance-related documentation.
Support deviation investigations, CAPA activities, and data integrity initiatives to ensure regulatory compliance.
Monitor manufacturing yields, process performance trends, and key performance indicators to identify and support continuous improvement opportunities.