Project Validation Specialist III

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 five (5) 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
  • EU MDR or MDD remediation projects, compliance projects and process validation required.
  • Managing documents within electronic PLM system
  • 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)

• Perform assessments and review of all manufacturing and validation documentation associated to product families established by EU MDR and Design History File (DHF) remediation program.
• Provide data to support the gap assessments reports and identify remedial action items based on the outcome of gap assessments.
• Complete assigned remediation activities to ensure that manufacturing processes and operations are in compliance with requirements of EU MDR.
• Generate and execute validation protocols, including the coordination of all activities required for protocol completion.
• Interact and coordinate activities with other departments, external vendors, and customers, as required.
• Update documentation associated with manufacturing processes which can include drawings, specifications, bill of materials, production router/instructions, procedures, labeling, and process flow charts, among others.
• Provide training in the updated manufacturing documentation as applicable.
• Analyze manufacturing process information / data, develop, where necessary, technical justification, rationale and/or other information as required by the company to mitigate risk to acceptable level with adequate documentation.
• Report project status and progress periodically to site management.
• Perform other related duties, as required.

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?