Flexible & Integrated Technical Services, LLC

Manufacturing Engineer (2nd Shift)

Process Engineer - Dorado, Puerto Rico - Contracted

 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?

Apply: Manufacturing Engineer (2nd Shift)
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