Associate Engineer

fitspr; Caguas (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

FITS is seeking an Engineering Quality professional in Puerto Rico to support pharmaceutical and medical device projects. The role focuses on developing product quality plans, quality specifications, risk analyses, and cross-site collaboration.

You will write and approve protocols, manage changes, monitor progress against the project plan, and lead investigations and troubleshooting with minimal supervision, while ensuring timely reports and quality improvements.

Qualifications

• Bachelor’s degree in Engineering required.
• Bilingual (English & Spanish) required.
• Project management skills are required.
• Experience in Manufacturing Process, Documentation, Validation Protocols, Investigations, and Troubleshooting.

Responsibilities

• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses.
• Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
• Anticipates potential situations that may impact project timelines and resolves them before they become an issue.
• Is the technical liaison with other cross functional areas with other sites.

Skills

Engineering Degree

Bilingual (English/Spanish)

Project Management

Manufacturing Process

Documentation

Validation Protocols

Investigations

Troubleshooting

Shift Flexibility

Education

Bachelor’s Degree in Engineering

Job description

For engineering services in the quality area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Engineering with experiencein the Pharmaceutical or Medical Device industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Second ( 1pm to 10pm)and according to business needs.
• Experience in:
  • Manufacturing Process
  • Documentacion
  • Validation Protocols
  • Investigations
  • Troubleshooting

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses.
• Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
• Anticipates potential situations that may impact projects timeline and resolves them before they become an issue.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Is the technical liaison with other cross functional areas with other sites.

WHO WE ARE:

We are a Service Provider companydifferent 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 industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?