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:
- 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?
Skills Required
- Bachelor's Degree in Science or Engineering
- Five years of experience in the validation life cycle
- Experience in Commissioning, Qualification, and validation
- Bilingual in English & Spanish
- Experience in Project Management
What We Do
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 We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
