Automation Engineer

For Automation services in the Manufacturing and Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Engineering and at least eight (8) years of experience in Automation and Validation activities within the Medical Device or Pharmaceutical industry.
• Bilingual: Spanish and English (verbal/ written)
• Shift: Administrative and according to business needs.
• Experience in:
  • Document digitization.
  • Test scripts development and execution.
  • CSV Documents revision and or development. 
  • GMP & GDP regulations.
  • Software Validation Life Cycle: IQ/OQ/PQ

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)

• Develop and configure control system software, including control modules, equipment modules, phase modules, and recipes.
• Generate and update user and design documentation for programming.
• Develop and execute test scripts and protocols.
• Perform system testing to identify critical component loss, prioritize component importance, and recommend recovery strategies using backup/restore procedures.
• Generate and execute qualification protocols (IQ, OQ, PQ).
• Ensure automated system operations comply with plant policies, procedures, and FDA regulations (cGMPs). Adhere to data integrity and system security practices
• Provide technical support for automated systems.
• Digitize paper forms and manage the generation, revision, and format changes of various documents, including CSV documentation, user documentation, and design documents.
• Prepare operational qualification assessments to ensure validated critical operating parameters are maintained.
• Support the evaluation of Change Controls to determine qualification assessments and performance qualification requirements during process modifications. Support periodic review of equipment/system qualification studies.
• Comply with individual learning plan requirements. Support onboarding and training processes.

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?