Validation Specialist

Flexible & Integrated Technical Services, LLCJuana Díaz, PR
Onsite

About The Position

For Validation services in the Manufacturing & Engineering area. 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 Be The Piece? 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!

Requirements

  • Bachelor Degree in Engineering or sciences
  • at least five (5) years of experience in Validation activities within the Pharmaceutical and/or Medical Devices industry.
  • Bilingual: (Spanish and English).
  • Problem-solving skills
  • excellent time management
  • good decision-making skills
  • Experience in Generation and execution of Equipment Manufacturing.
  • Experience in Protocols and Change Control.

Responsibilities

  • Develop and approval validation protocols.
  • Validation Protocols execution.
  • Develop required Change Control.
  • Support in the document approval process.
  • Develop final report.
  • Provide the needed documents for all implementations and activities on project.
  • Assist facilities qualifications/commissioning and validation activities.
  • Coordinate multiple equipment documentation through suppliers & contractors.
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