Senior Validation Engineer

3 weeks ago


San Jose, California, United States MILLENNIUMSOFT Full time
Job Title: Senior Validation Engineer

We are seeking a highly skilled Senior Validation Engineer to join our team at Millenniumsoft. As a Senior Validation Engineer, you will be responsible for performing process, equipment, and software validation activities, including gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and reports, and final approval of validation protocols, reports, and deviations.

Responsibilities:

• Perform process, equipment, and software validation activities, including IQ, OQ, and PQ.

• Gather historical data for product manufacture and analyze data using statistical principles.

• Write validation protocols and reports, and obtain final approval of validation protocols, reports, and deviations.

• Collaborate with cross-functional teams, including Reagent Manufacturing Engineers and Chemists, Research and Development, and Quality Assurance Validation Engineers.

Requirements:

• Bachelor's degree in a relevant field.

• Experience in a quality-related function in a medical device or other FDA-regulated environment.

• Process validation (IQ, OQ, PQ) and test method validation experience.

• Software validation experience.

• Knowledge of general reagent manufacturing processes, antibody purification and conjugation, and flow cytometry.

• Certified Quality Engineer or Six Sigma Certification.

• Training in statistics and experience with Minitab or other statistical software, MS Excel, and MS Word.

Preferred Skills:

• Root Cause Analysis

• FMEA

• Risk Management and Mitigation

• DOE

• Measurement Systems Analysis

• Sampling and Control Plans

• Post Market Surveillance Trend Review

• Process Capability

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