C&Q Lead
Barceloneta, PR, Puerto Rico
Contracted
Pharmaceutical
Experienced
For C&Q services in Engineering area.
WHAT MAKES YOU A FIT: .png)
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.
WHO WERE 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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