About the role
For Manufacturing services in the Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
* Bachelor's Degree in Mechanical, Electrical, Industrial, Manufacturing, or Biomedical Engineering, or a related technical field, and 2–3 + years of experience manufacturing environment, including the generation and execution of validation protocols for manufacturing equipment. * Bilingual (English & Spanish). * Shift: 2nd shift (12:00pm-9:00pm) and according to business needs. * Experience in: * Generation and execution of validation protocols for manufacturing equipment. * Qualification, validation, and lifecycle management of manufacturing systems and equipment. * GMP documentation development, including protocols, reports, risk assessments, deviations, and CAPAs. * Manufacturing process support, troubleshooting, compliance, and continuous improvement initiatives.
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
Key Responsibilities include, but are not limited to, the following:
* 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.
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the next piece?