Engineer Validation Jobs

Hi this is harsha a senior technical scout from intellectt inc.As we do have an job opening for Engineer Validation if you are interested please send me your resume for [email protected] or you can call me at +1 732-276-1830
Role: Engineer Validation II
Location: 2350 Qume Drive, San Jose, CA, USA, 95131-1807
Description

• Follows company procedures
• Demonstrates working knowledge and application of applicable regulatory requirements
• DOE
• Process, Test Method, Equipment, and Software Validations used in IVD product manufacture (IQ, OQ, PQ)
• Responsible for performing process, equipment, and software validation activities including, but not limited to, gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and reports, GDP review of data and reports, and final approval of validation protocols, reports, and deviations.
• May be responsible for leading teams to perform validation activities or perform as a member of the team.
• Sampling and Control Plans
• May interact in cross-functional teams including Reagent Manufacturing Engineers and Chemists, Research and Development, and Quality Assurance Validation Engineers.
• Provides and applies quality engineering direction to projects using quality engineering and statistical principles
• Other duties as assigned.
• Post Market Surveillance Trend Review
• Provides and applies scientific technical principles/concepts
• Knowledge of general reagent manufacturing processes, antibody purification and conjugation, and flow cytometry, is preferred.
• FMEA
• Will simultaneously work on multiple projects.
• Acts as Quality Assurance reviewer/approver or author for validation protocols, reports, and deviations.
• Root Cause Analysis
• Process Capability
• Risk Management and Mitigation

Education: bachelor's degree
Experience (preferred)

• Process validation (IQ, OQ, PQ) and test method validation experience Software validation experience
• Experience in a quality related function in a medical device or other FDA regulated environment. Previous work with IVD reagent products under GMP conditions
• Knowledge of applicable regulatory requirements including ISO13485, ISO14971, ISO9001, quality systems regulations (21 CFR: 820)
• Six Sigma Certification
• Certified Quality Engineer
• Experience with Minitab or other statistical software, MS Excel, and MS Word required
• Knowledge of general reagent manufacturing processes, antibody purification and conjugation, flow cytometry
• Training in statistics.