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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

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