Project Validation Specialist

Añasco, PR, Puerto Rico
Contracted
Medical Device
Experienced

For Project Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree in Engineering or Science and at least seven (7) years of exposure to sterilization activities within the Pharmaceutical or Medical Devices industry. ,
  • Bilingual (Spanish and English)
  • Shift: Administrative & according to business needs 
  • Experience in:
    • Validation Life Cycle
    • GMP & GDP regulations

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)

  • Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.
  • Gap Assessments – Assess all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans, and process validations, among others.
  • Remediation Plan – Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical.

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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