Manufacturing Engineer (2nd Shift)

For Manufacturing services in the Engineering a rea.

About fitspr

• 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?

Responsibilities

• 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.

Requirements

• 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.