What are the responsibilities and job description for the Validation Engineer position at KAYConnect LLC?
Job Title: Validation Engineer
Duration: 6 months
Location: Bloomington, IN - Onsite
Mode of interview: One and done virtual
Need help with this order for an Onsite Validation Engineer with 3-5 years’ experience.
Review of process validations for identification of gaps to internal and external requirements. Test Method Validation and Process Validation protocol generation, execution, and report generation per applicable Quality System Procedures and Instructions This Engineering position will work within Pk48 Production Engineering - Process Validation
Department and with other functional groups, as needed, to identify process validation needs. Demonstrate the understanding of medical device regulations and best practices Demonstrate knowledge of medical device regulation (ISO 13485, 21 CFR) and risk
management (ISO 14971). Demonstrate a proficiency in statistical, quality, and continuous improvement methods and Tools