Validation Engineer

For Engineering services in the Extrusion and Manufacturing area.

E xecuting 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.

About fitspr

Are you ready to Be The Piece?

• 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?

Responsibilities

• 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.

Requirements

• 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.
• Spanish and English Soft Skills: Excellent communication skills and a positive attitude.

Shift

1st and according to business needs.