Validation Lead (C&Q)

For C&Q services in Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's Degree in Science or Engineering with five (5) years of experience in the validation life cycle, within the pharmaceutical industry.
• Bilingual (English & Spanish).
• Shift: Administrative, and according to business needs. 
• Experience in: 
  • Generation & Execution Protocols Commissioning, Qualification, and validation.
  • Develop validation engineering policies and procedures.
  • Project Management and lead

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 Be The Piece?

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

• Lead the development and execution of C&Q strategies for process systems, equipment, utilities, and facilities in support of biotech manufacturing operations.
• Define C&Q scope, deliverables, and lifecycle approach aligned with GMP, FDA, EMA, and applicable regulatory expectations.
• Develop, review, and approve C&Q documentation including risk assessments, protocols (IQ/OQ/PQ), test scripts, summary reports, and turnover packages.
• Coordinate and lead commissioning and qualification activities during design, construction, installation, and start‑up phases.
• Serve as the primary C&Q point of contact between Engineering, Process, Automation, Quality, and Operations teams.
• Ensure effective integration of C&Q activities with project schedules, construction milestones, and startup plans.
• Provide leadership and oversight to internal teams, contractors, consultants, and vendors performing C&Q activities.
• Identify, communicate, and mitigate C&Q risks that may impact project compliance, schedule, or cost.
• Ensure deviations, discrepancies, and change controls related to C&Q activities are properly managed and resolved.
• Support regulatory inspections, audits, and internal quality reviews related to commissioned and qualified systems.
• Prepare and present regular status updates to project and site leadership on C&Q progress, risks, and readiness.

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?