For Validation services in the New Product Introduction area.
WHAT MAKES YOU A FIT: The Technical Part:- Bachelor's degree in Engineering and at least three (3) years of previous experience in extrusion process development or manufacturing activities within the Pharmaceutical & Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent communication skills and a positive attitude.
- Shift: Administrative shift (M-F 8:00AM to 5:00PM)
- Experience in:
- New Production Introduction/New Product Development
- Executing process validation (IQ/OQ/PQ)
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.
- Other project related tasks as needed.
- Provide training to associates or technicians.
- Participate in equipment, FAT/SAT, and installation activities.
- Contribute to cost reduction and capacity planning initiatives.
