Validation Engineer - San Diego

Company: Katalyst HealthCares & Life Sciences Inc
Your Application: You have not applied yet
Location: San Diego, USA

Job Description:

Create Master Validation plan (MVP) in coordination with different stakeholders Hands on experience in Method Transfer, Process Validation (IQ /OQ /PQ), Validation performance and Reports. Working on sample size determination, creating sample size for Testing's, for Design Verification, Validation, Process Validation and Test Method Validation Hands on experience working on Validation reports for the Manufacturing site that are moving from one place to another. This includes Facility Validation as well. Hands on experience on drafting Protocols, Testing, Data Analysis and Test Reports Extensive Experience on using Minitab for Data Analysis, R&R Analysis after Test Execution Understanding on Software elements would be an added advantage Knowledge on IVDR and DHF Remediation also will be an added advantage Good understanding on Requirements analysis (Customer Reqs, Technical Reqs, Functional /Product Reqs), Traceability Matrix, DHF Remediation and Risk Management with
FMEA working. Experience with QC Tools and Statistical Methods Understand Product BOMs and Assessment with reference to information available in PLM/Other Repository Working closely with customer counterparts and understanding their Requirements and working on collaborative mode. Understand the customer requirements and suggest alternative feasible concepts. Familiar with Engineering Change Orders and Engineering Change Notes Proven track record of problem solving Knowledge in Mechanical Design, Bill of Materials, Product Life Cycle stages Provide Project status updates to the work group, tracking the overall project implementation. Good Communication and documentation skills. Good knowledge in MS PowerPoint and Excel
Minimum required education: Bachelors Degree
Employment type: Other

Work Day: Full Time
Salary: Negotiable

Minimal experience: 23 years

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