CamarilloRecruiter Since 2001
the smart solution for Camarillo jobs

Quality Engineer - Validation

Company: Astrix
Location: Camarillo
Posted on: July 29, 2022

Job Description:

We are seeking a Quality Engineer to support product development, product transfer, manufacturing, and commercialization of bioreactor products. This position incorporates elements of medical device design control, standards for GMP bioprocessing equipment, and single-use medical products to define requirements for testing, qualification, verification, and validation. Please let me know if you are interested.Terms: Direct HireSalary: $80k-110,000; DOEJob Duties and Accountabilities:--- Provide Quality Engineering analysis and assessments for impact to product quality/validation to support changes, investigations, CAPA, nonconformances, and manufacturing processes.--- Review technical documents as quality approver.--- Quality contact for validation of manufacturing process, facility, and equipment.--- Supports and may own elements of the validation program including procedures, validation master plan, product qualification, and related training.--- Manage or support periodic validation and testing for product, equipment, and facility. Including studies for process monitoring, radiation sterilization, shipping/transport, packaging, and shelf-life.--- Organize and manage product test samples and lab results for testing of bioburden, particulates, endotoxin, biocompatibility, and extractables.Required Education and Experience:--- A bachelor's degree in a science field is acceptable with --- 3 years of industry experience.--- Minimum 2 years in a Quality Engineering or Validation role, or 3 years in a related role such as Product Development Engineering, Manufacturing Engineering, or Industrial Engineering.--- Minimum 2 years of experience working with products regulated by GMP/biopharma (21 CFR 210/211, ICH Q7/10), medical products field, or other regulated industry (aerospace/AS910

Keywords: Astrix, Camarillo , Quality Engineer - Validation, Engineering , Camarillo, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Camarillo RSS job feeds