August 11, 2022 A Technology Blog

Job Opening for Validation Engineer in Katalyst Healthcares & Life Sciences (Covington, GA 30014)

Hello,   If you are looking for an Engineering Job ? Then, This is the place where you can find All sources of Job opportunities with detailed information.
Job Category : Engineering
Company Name: Katalyst Healthcares & Life Sciences
Position Name: Validation Engineer
Location : Covington, GA 30014
Job Description : Responsibilities: Provide leadership and support for quality objectives and process improvement efforts, serving as designee for the QA Ops Manager, as necessary. Provides technical input and leadership for projects using the application of FMEA’s, risk mitigation, plant validations, DOE’s and other experiments and investigations as assigned. Lead, own, and/or provide guidance/mentoring for investigations (investigations pertaining to CAPA, Audit response(s), DMAIC/Failure Investigations, etc.). Identify, implement, and monitor procedures and systems to support 21CFR 820, ISO 13485, and the European Medical Device Regulations. Creates/reviews Protocols, Process and Product Validations, and Test Methods. Creates and reviews Risk Assessments such as FMEA and/or FTA. Other duties as assigned Requirements: BA/BS in a scientific discipline (Engineering, Engineering Technology, Chemical/Biological or equivalent). 3 years medical device, pharmaceutical experience or in a regulated industry. 3 years of medical device /pharmaceutical validation, to include manufacturing equipment/process qualifications (IQ, OQ, PQ) Demonstrated knowledge and experience in problem solving, validations, CAPA, and investigations (Failure, DMAIC, complaint, etc.). ASQ certification (CQE, CQA, etc…) preferred Advanced Statistics or Green/Black Belt / Six Sigma training highly desirable. Experience with Value Stream Analysis and LEAN Methods highly desirable. Proficiency in variety of Microsoft applications including Word, Excel, Visio, PowerPoint, and Minitab or applicable statistical analysis software. Experience working with regulatory and statutory agencies (FDA, Notified Bodies, etc.). Experience working with Lean and Six Sigma methodologies
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