Validation Engineer

Flexible & Integrated Technical Services, LLC•Añasco, PR

8d•Onsite

About The Position

For Validation services in the New Product Introduction area. This role involves supporting the development and optimization of extrusion processes for medical tubing and components, participating in process validation activities, and collaborating with various departments to ensure project milestones are met. The position also includes developing and maintaining documentation, analyzing process data, and supporting new product introduction efforts.

Requirements

Bachelor’s degree in Engineering
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
Excellent communication skills
Positive attitude
Experience in New Production Introduction/New Product Development
Experience in Executing process validation (IQ/OQ/PQ)

Responsibilities

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.