Sr. CQV Lead

For Commissioning, Qualification and Validation services in the Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Engineering and at least six (6) years of experience in CQV activities within the Pharmaceutical or Medical Device industry. 
• Shift: Administrative & according to business needs
• Bilingual: (Spanish and English)  
• Be available to work in a fast paced project and environment
• Six Sigma & PMP Certifications (preferred)
• Experience in:
  • FDA/EMA/ICH Regulations 
  • Development of Project Quality & Commissioning and Qualification Plan 
  • Packaging
  • Qualification processes in general (room, utilities, EMPQ), cGMP practices and standards.
  • Validation Master Planning 

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)

• Ability to communicate with senior leadership and strategize to complete project as planned.
• Resource must work on his own and report to the Project Manager for status, progress and issues discussion.
• Must work in hand to hand with Document Control and Validation Site teams in order to develop, execute and transfer required documents.
• Align with external vendors to ensure resources are on site to support qualification activities.
• Communicate, align and coordinate with Facilities and Engineering team for support on OT/AUT and Maintenance Support.
• Conduct CSV assessment and execution for the filling operation and potentially other project initiatives.
• Manage new equipment introduction process until closeout including the setup for CMMS.

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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