Validation Engineer
Flexible & Integrated Technical Services, LLC · fitspr.com
AñascoOn-siteContract
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The job in short
Validation engineering for medical device manufacturing: protocols, change control, qualification.
Details
- Found
- 15 d ago · posted 2026-10-07
- Location as listed
- Añasco, PR
- Role
- Engineer (other)
- Source
- The company’s own careers site
Full description
For Validation services in the Engineering & Manufacturing areas.
WHAT MAKES YOU A FIT:
The Technical Part:
• Bachelor's Degree in Engineering and previous exposure to validation quality activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
• Protocol development, execution, investigations, and technical documentation.
• Minitab, JMP, or similar statistical analysis tools.
• EO/EtO sterilization processes and validation activities (preferred)
• Working with external suppliers and supplier qualification projects (preferred)
• GMP & GDP
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)
• Development and execution support of validation protocols and reports.
• Change control support (CRs, TRs, VPs, protocol execution, evidence compilation, and closure activities).
• Qualification and operational readiness activities across systems, processes, and infrastructure.
• Cross-functional coordination with Engineering, Quality, Operations, Planning, Supply Chain, and external suppliers.
• Support for SOP updates, training, UAT activities, implementation readiness, and post-implementation support.
• Technical support for supplier qualification and validation activities.
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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