Validation Engineer

1 week ago


Medina, United States Premier Life Sciences LLC Full time

Not for C2C


Title: USA - Validation Engineer

Locations: Medina NY

Duration: 3+ Months + Extensions


Write reports summarizing results and statistics for all equipment, product, or process validation projects.

Trend and report on the Manufacturing NCRs – including process effectiveness and corrective and preventative actions and make recommendations for improvements.

Develop and communicates expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.

Support the Quality Management System

Lead the development and execution of engineering studies, quality plans, validation packages

Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.

Knowledge and working application of reading and understanding blue prints and technical drawings.

Desired CQE, CSSBB, CQA or initiative to complete certifications.

Prefer experience with TQM methods (e.g. "six sigma").

Internal Quality System auditing experience (ISO 13485 and FDA 21CFR820).



REQUIRED

Bachelor’s degree in Engineering

5-8 years of related experience

Six Sigma Certification (. Belt or Black Belt) is desirable


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