Validation Engineer
- Añasco, Puerto Rico
- Mid Level
- Posted
For Validation services in the Engineering & Manufacturing areas.
About Flexible & Integrated Technical Services, LLC
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?
- 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?
Responsibilities
- 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.
- 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.
Requirements
- 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.
Benefits
- In other words, being a customer service pro is one your (many) talents.
