Associate Engineer

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

Job summary

FITS, LLC is seeking a Quality Engineer for the second shift (1pm–10pm) to support pharmaceutical and medical device projects.

The role requires a Bachelor’s in Engineering and hands-on experience with manufacturing processes, validation, investigations, and corrective actions. You will write protocols and participate in change control while collaborating with multiple teams.

Qualifications

• Bachelor’s degree in Engineering with pharma/medical device experience.
• Experience with manufacturing processes and validation protocols.
• Ability to write and approve protocols and reports with minimal supervision.

Responsibilities

• Develops product quality plans, documents and systems by providing input to product specifications and risk analyses.
• Implements changes through change management and assesses quality impact.
• Write and approve protocols and reports to support engineering studies and validations.
• Generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
• Anticipate potential situations that may impact timelines and resolve them.
• Act as technical liaison with cross-functional areas and other sites.

Skills

Engineering Degree

Pharma/MedTech exp

Quality Engineering

Troubleshooting

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.
• 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!