Manufacturing Engineering Lead

FITS LLC; Añasco (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Manufacturing Engineer to support the Base Business area. The role requires a Engineering degree and 4+ years in pharmaceutical or medical device manufacturing, with bilingual English/Spanish communication and ability to adapt shifts as needed.

Candidates should have hands-on experience with manufacturing systems and tools such as Agile, Cognex, Box, and SAP, plus strong Excel/Minitab skills for data analysis and reporting.

Qualifications

• Bachelor's Degree in Engineering and at least four (4) years of experience in Manufacturing within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication).
• Shift: Administrative & according to business needs.
• Experience in manufacturing systems and digital tools such as Agile, Cognex, Box, SAP, and other engineering/business applications.
• Microsoft Excel, Minitab, and general statistical analysis, with the ability to prepare accurate reports, documentation, and support data-driven decisions.

Responsibilities

• Ensure that all new and existing protocols are integrated into manufacturing processes.
• Ensure documentation is thorough, accurate, and entered on a timely basis into the quality system.
• Ensure complete and thorough investigation of all product failures, batch failures, and deviations related to validation sampling and testing.
• Develop documentation of investigations and communicate findings to minimize recurrence and satisfy client requirements.
• Develop and implement process strategies, optimize current processes, and maintain process documents.
• Support day-to-day process operations.

Skills

Bilingual (Spanish/English)

Manufacturing systems

Agile

Cognex

Box

SAP

Excel

Minitab

Statistical analysis

Education

Bachelor's Degree in Engineering

Tools

SAP

Cognex

Box

Agile

Excel

Minitab

Job description

For Manufacturing Engineering services in the Base Business area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree inEngineering and at least four(4) years of previous exposure to Manufacturing activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
  • Manufacturing systems and digital tools such as Agile, Cognex, Box, SAP, and other engineering/business applications. Ability to troubleshoot system-related issues and quickly learn new technologies.
  • Microsoft Excel, Minitab, and general statistical analysis, with the ability to prepare accurate reports, documentation, and support data-driven decisions.

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)

• Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
• Ensure documentation is thorough, accurate, and entered on a timely basis into the quality system.
• Ensures complete and thorough investigation of all product failures, batch failures, and deviations associated with validation sampling and testing.
• Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies client requirements.
• Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents.
• Support the day-to-day process operations.

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?