Validation Engineer
Añasco, PR, Puerto Rico
Contracted
Medical Devices
Mid Level
For Engineering services in the Extrusion and Manufacturing area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s degree in Engineering or related field and at least two (2) years of Extrusion Process Development or Manufacturing experience within the Pharmaceutical & Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent communication skills and a positive attitude.
- Shift: 1st and according to business needs.
- Experience in:
- Executing process validation (IQ/OQ/PQ)
- NPI/NPD
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 of 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)
- Support development and optimization of extrusion processes for medical tubing and components.
- Assist in design of experiments (DOE) to evaluate process parameters (temperature profiles, screw speed, puller rates, etc.).
- Participate in process validation activities and documentation per FDA/ISO requirements.
- Collaborate with R&D, Quality, Regulatory, Manufacturing, and Supply Chain to ensure alignment and execution of project milestones.
- Develop and maintain documentation including design history files (DHF), process development reports, validation protocols, and work instructions & Collect, analyze, and interpret process data to drive improvements in yield, quality, and capability.
- Support new product introduction (NPI) efforts including prototyping, trials, and line setup.
- Assist in development and updates of standard operating procedures (SOPs) and work instructions.
- Document experimental results and prepare technical reports and presentations.
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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