Validation Engineer

Añasco, PR, Puerto Rico
Contracted
Medical Devices
Mid Level

For Test Method Validation services in the Engineering area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s degree in Engineering and at least seven (7) years of previous experience within the Pharmaceutical & Medical Devices Industry.
  • Bilingual: Spanish and English
  • Soft Skills: Excellent communication skills and a positive attitude. 
  • Shift: Administrative shift (M-F 8:00AM to 5:00PM), must have flexibility to work hours between 6:30AM to 5:00PM. 
  • Experience in:
    • Validation methods 
    • Statistics 
    • Incoming and receiving processes 
    • Equipment validation and installation 

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 of 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 Be The Piece?

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

  • Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards mplex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
  • Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
  • Develop training and documentation materials (e.g., work instructions) for production to enable the
    seamless knowledge transfer of project and manufacturing processes.
  • Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
  • Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
  • Mainly, execute Test methods validation (ATMV / VTMV) for measuring equipments at receiving Inspection area.

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?

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